Laparoscope, Gynecologic (And Accessories)

FDA product code HET · 336 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.1720
Review panel: OB
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-03-09 – 2025-08-29

HET 1996-04-15

CORING MORCELLATOR

Applicant Cook Urological, Inc.

K number K960262

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HET 1996-04-11

KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K951343

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HET 1996-03-11

OES LAPARO-THORACO VIDEOSCOPE TYPE V

Applicant Olympus America, Inc.

K number K955403

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HET 1996-02-22

OES LAPARO-THORACO VIDEOSCOPE (RIGID)

Applicant Olympus America, Inc.

K number K955456

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HET 1996-02-16

TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES

Applicant Hogan & Hartson

K number K942389

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HET 1996-01-11

R-MED ABDOMINAL WALL ELEVATOR

Applicant R-Med, Inc.

K number K953360

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HET 1995-12-22

INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS

Applicant Materials Conversion Corp.

K number K952889

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HET 1995-12-08

SPECULITE

Applicant Trylon Corp.

K number K953364

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HET 1995-11-17

OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM

Applicant Olympus America, Inc.

K number K943305

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HET 1995-11-06

KARL STORZ TAKE-APART BIOPOLAR FORCEPS

Applicant KARL STORZ Endoscopy-America, Inc.

K number K953809

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HET 1995-10-31

OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN

Applicant Olympus America, Inc.

K number K942838

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HET 1995-10-20

KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP

Applicant KARL STORZ Endoscopy-America, Inc.

K number K951105

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HET 1995-10-16

MICROSURGE VERESS NEEDLE

Applicant Microsurge, Inc.

K number K954520

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HET 1995-10-11

LAPOROSCOPIC SCISSORS

Applicant Enterprise Medical Corp.

K number K942431

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HET 1995-10-05

KSEA MODEL 203200 20 UNIMAT

Applicant KARL STORZ Endoscopy-America, Inc.

K number K953190

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HET 1995-09-29

NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER

Applicant American Hydro-Surgical Instruments, Inc.

K number K953574

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HET 1995-09-28

PATTON LAPAROSCOPIC CATHETER INTRODUCER SET

Applicant Cook Urological, Inc.

K number K940265

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HET 1995-09-19

LAPAROSCOPIC SURGICAL INSTRUMENT

Applicant Gabris Surgical Corp.

K number K953548

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HET 1995-09-15

HI-Q HAND INSTRUMENTS, OB/GYN USE

Applicant Olympus America, Inc.

K number K944200

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HET 1995-09-07

KARL STORZ SUCTION CATHETERS

Applicant KARL STORZ Endoscopy-America, Inc.

K number K951250

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HET 1995-08-25

FLOW-THERME, WISAP #7642

Applicant Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

K number K952508

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HET 1995-08-10

STRYKER OPERATING LAPAROSCOPE

Applicant Stryker Endoscopy

K number K943100

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HET 1995-07-25

CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS

Applicant Chirurgische Instrumente

K number K944270

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HET 1995-07-25

DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE

Applicant New Eder Corp.

K number K941206

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HET 1995-07-20

KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE

Applicant KARL STORZ Endoscopy-America, Inc.

K number K951394

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HET 1995-07-12

KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT

Applicant KARL STORZ Endoscopy-America, Inc.

K number K950962

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HET 1995-07-06

NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)

Applicant American Hydro-Surgical Instruments, Inc.

K number K946380

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HET 1995-06-30

TORCARS,CANNULAE,SHEATHS,OBTURATORS

Applicant Karl Storz Endoskop GmbH

K number K943713

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HET 1995-06-14

KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE

Applicant KARL STORZ Endoscopy-America, Inc.

K number K951190

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HET 1995-06-13

LASEVAC

Applicant D.D. Surgical, Inc.

K number K951490

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HET 1995-05-25

KSE STEINER ELECTROMECHANIC MORCELLATOR

Applicant KARL STORZ Endoscopy-America, Inc.

K number K946147

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HET 1995-05-25

LAPARASCOPE

Applicant Pollux Endoscopy, Inc.

K number K943662

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HET 1995-05-11

R-MED MINI-RETRACTOR

Applicant R-Med, Inc.

K number K950108

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HET 1995-05-11

KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS

Applicant KARL STORZ Endoscopy-America, Inc.

K number K946359

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HET 1995-05-05

CANNUAL AND TROCAR, SUPERPUBIC

Applicant Core Dynamics, Inc.

K number K950457

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HET 1995-05-05

KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS

Applicant KARL STORZ Endoscopy-America, Inc.

K number K945685

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HET 1995-04-25

AESCULAP LAPAROSCOPES

Applicant Aesculap, Inc.

K number K942730

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HET 1995-03-31

R-MED DISPOSABLE PLUG

Applicant R-Med, Inc.

K number K942411

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HET 1995-03-30

KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE

Applicant KARL STORZ Endoscopy-America, Inc.

K number K945211

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HET 1995-03-29

AESCULAP LAPAROSCOPIC ANCILLARY DEVICES

Applicant Aesculap, Inc.

K number K943603

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HET 1995-03-21

KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER

Applicant KARL STORZ Endoscopy-America, Inc.

K number K945982

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HET 1995-03-21

KSEA SEMM TISSUR PUNCH

Applicant Karl Storz Endoskop GmbH

K number K943053

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HET 1995-03-21

BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.

Applicant Birtcher Medical Systems, Inc.

K number K932779

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HET 1995-03-16

LAPAROSCOPE AND ACCESSORIES FOR OB/GYN

Applicant Olympus America, Inc.

K number K950232

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HET 1995-03-06

THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM

Applicant Sanese Medical Corp.

K number K941507

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HET 1995-03-06

CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL

Applicant Conceptus, Inc.

K number K932387

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HET 1995-02-28

TROCAR AND CANNULA ACCESSORY

Applicant Applied Medical Resources

K number K945741

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HET 1995-02-28

CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020

Applicant KARL STORZ Endoscopy-America, Inc.

K number K932276

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HET 1995-02-27

HASSON STABILIZING ACCESS CANNULA (SAC)

Applicant Entec Corp.

K number K942973

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HET 1995-02-13

CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE

Applicant Conmedcorp

K number K946235

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HET 1995-01-26

CIT TWO WAY SUCTIN AND IRRIGATION TUBES

Applicant Chirurgische Instrumente

K number K944268

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HET 1995-01-26

IMAGYN MICROLAP INTRODUCER

Applicant Imagyn Medical, Inc.

K number K943810

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HET 1995-01-24

KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE

Applicant KARL STORZ Endoscopy-America, Inc.

K number K945100

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HET 1995-01-24

CIT GRASPING AND DISSECTING FORCEPS

Applicant Chirurgische Instrumente

K number K944269

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HET 1995-01-20

IMAGYN MICROLAP(TM) LAPAROSCOPE

Applicant Imagyn Medical, Inc.

K number K944079

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HET 1995-01-06

STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360

Applicant Baxter Healthcare Corp

K number K936273

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HET 1994-12-30

ENDOSCOPE

Applicant United States Surgical, A Division of Tyco Healthc

K number K944555

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HET 1994-12-27

FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS

Applicant Marlow Surgical Technologies, Inc.

K number K944563

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HET 1994-12-21

CONMED TROGARD

Applicant Conmedcorp

K number K934799

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HET 1994-12-15

HASSON OPEN LAPAROSCOPY CANNULA

Applicant Linvatec Corp.

K number K942447

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HET 1994-11-30

LAPAROVIEW

Applicant Northgate Technologies, Inc.

K number K931065

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HET 1994-11-17

INSUFFLATOR TUBING WITH FILTER

Applicant Stryker Endoscopy

K number K943508

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HET 1994-11-15

DYNABITE LAPAROSCOPIC FORCEPS

Applicant Portlyn Corp.

K number K944245

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HET 1994-10-20

IMAGYN LAPAROSCOPIC INSTRUMENTS

Applicant Imagyn Medical, Inc.

K number K944129

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HET 1994-10-18

FLEXIBLE FIBER OPTIC LAPAROSCOPES

Applicant Optimed Technologies, Inc.

K number K943598

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HET 1994-09-28

ZEISS OPMI L STEREO-LAPAROSCOPE

Applicant Carl Zeiss, Inc.

K number K931478

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HET 1994-09-21

INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM

Applicant Invamed, Inc.

K number K936011

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HET 1994-09-14

SURGIMAT

Applicant W.O.M. World of Medicine GmbH

K number K926259

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HET 1994-08-24

LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)

Applicant Endo Technic Corp.

K number K925079

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HET 1994-08-19

SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

Applicant Smith & Nephew Dyonics, Inc.

K number K936071

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HET 1994-07-25

TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE

Applicant Tahoe Surgical Instruments P.R., Inc.

K number K941944

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HET 1994-07-22

INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS

Applicant Innervision, Inc.

K number K940718

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HET 1994-07-20

VIDEO ENDOSCOPE-RIGID MODIFICATION

Applicant Medical Dynamics, Inc.

K number K921294

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HET 1994-07-12

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Applicant Optimed Technologies, Inc.

K number K926597

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HET 1994-06-30

IRRIGATION PUMP AND TUBING SET

Applicant Marlo Surgical Technology

K number K924611

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HET 1994-06-27

COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES

Applicant Mahe-Medizintechnik

K number K933768

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HET 1994-06-21

ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)

Applicant Uresil Corp.

K number K940505

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HET 1994-06-17

DIAGNOSTIC SLEEVE, REDUCER SLEEVE

Applicant New Eder Corp.

K number K941208

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HET 1994-06-14

DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE

Applicant Davol, Inc.

K number K941334

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HET 1994-06-10

OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES

Applicant Owens Industries, Inc.

K number K926596

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HET 1994-06-09

LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED

Applicant Imtec Corp.

K number K923260

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HET 1994-06-06

OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES

Applicant Owens Industries, Inc.

K number K926594

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HET 1994-05-19

SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS

Applicant Baxter Healthcare Corp

K number K940709

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HET 1994-05-11

KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K935785

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HET 1994-05-10

INSUFFLATION TUBING & FILTER

Applicant H & C Chemical, Inc.

K number K941094

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HET 1994-05-10

HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION

Applicant KARL STORZ Endoscopy-America, Inc.

K number K940462

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HET 1994-05-06

KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS

Applicant Baxter Healthcare Corp

K number K940049

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HET 1994-05-02

MYOMA DRILL 5MM-8383.611

Applicant Richard Wolf Medical Instruments Corp.

K number K940844

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HET 1994-05-02

BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA

Applicant Bard Reproductive Systems

K number K921722

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HET 1994-04-28

ENDOSCOPE

Applicant United States Surgical, A Division of Tyco Healthc

K number K925968

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HET 1994-04-25

RIZA-RIBE NEEDLE

Applicant R-Med, Inc.

K number K935031

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HET 1994-04-25

BIRTCHER ENDOSCOPIC CORKSCREW

Applicant Birtcher Medical Systems, Inc.

K number K931771

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HET 1994-04-25

BIRTCHER MAGNETIC RETRIEVER (GS-3100)

Applicant Birtcher Medical Systems, Inc.

K number K931654

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HET 1994-04-22

ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS

Applicant Sharpe Endosurgical Corp.

K number K941494

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HET 1994-04-11

LAPRO-LOADER(TM)

Applicant Surgimark, Inc.

K number K932689

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HET 1994-04-11

LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS

Applicant Imtec Corp.

K number K923259

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HET 1994-04-07

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE

Applicant Zinnanti Surgical Instruments, Inc.

K number K926021

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HET 1994-03-25

ESYS SYSTEM

Applicant Endolap, Inc.

K number K933492

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HET 1994-03-22

DYNABITE HYSTEROSCOPIC FORCEPS

Applicant Portlyn Corp.

K number K934506

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HET 1994-03-17

HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS

Applicant Cook Urological, Inc.

K number K934451

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