Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

FDA product code ERL · 87 cleared devices

Class 2 Ear, Nose, Throat

Regulation: 21 CFR 874.4250
Review panel: EN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-08-31 – 2025-07-03

ERL 2025-07-03

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

Applicant W&H Dentalwerk Buermoos GmbH

K number K243280

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ERL 2024-03-14

hekaDrill

Applicant Zethon, Ltd.

K number K233958

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ERL 2022-11-02

ORiGO System

Applicant Bien-Air Surgery SA

K number K221184

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ERL 2022-05-26

AMADEO, M-UK1015 (incl. attachments and accessories)

Applicant W&H Dentalwerk Buermoss GmbH

K number K213221

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ERL 2022-01-19

Celeris, Disposable Sinus Debrider

Applicant Gyrus Acmi, Inc.

K number K212650

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ERL 2021-06-09

Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000

Applicant Stryker Corporation

K number K211490

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ERL 2020-10-22

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

Applicant KARL STORZ Endoscopy-America, Inc.

K number K200318

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ERL 2019-12-13

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand

Applicant Interscope, Inc.

K number K190715

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ERL 2018-03-27

OCM-G1 Attachment

Applicant The Anspach Effort, Inc.

K number K180063

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ERL 2017-09-15

Stryker Consolidated Operating Room Equipment (CORE) 2 Console

Applicant Stryker Corporation

K number K171840

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ERL 2017-03-09

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider

Applicant Laurimed, LLC

K number K163247

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ERL 2016-08-25

DragonFly Surgical Drill System

Applicant Grace Medical, Inc.

K number K161376

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ERL 2016-06-22

PolypVac Microdebrider (3.3mm and 4.0mm)

Applicant Laurimed, LLC

K number K161101

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ERL 2016-06-10

DIEGO ELITE DRILL

Applicant Gyrus Acmi, Inc.

K number K152744

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ERL 2016-01-08

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

Applicant Karl Storz Endoscopy America, Inc.

K number K150969

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ERL 2013-12-31

ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM

Applicant The Anspach Effort, Inc.

K number K131053

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ERL 2013-12-23

LAURIMED POLYPVAC MICRODEBRIDER

Applicant Laurimed, LLC

K number K133133

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ERL 2012-08-30

DTAD

Applicant Gyrus Acmi, Inc.

K number K121678

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ERL 2012-05-01

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

Applicant Stryker Corporation

K number K112593

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ERL 2009-03-20

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K

Applicant Bien-Air Surgery SA

K number K083720

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ERL 2008-12-17

REPROCESSED ENT SHAVERS

Applicant Sterilmed, Inc.

K number K081814

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ERL 2008-10-02

STRYKER ESSX WITH NAVIGATION MOUNT

Applicant Stryker Corp.

K number K080052

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ERL 2008-09-17

PRIMADO SURGICAL DRILL

Applicant Nakanishi, Inc.

K number K080722

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ERL 2008-09-05

XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)

Applicant Medtronic Xomed, Inc.

K number K081277

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ERL 2008-08-26

STRYKER ESSX MICRODEBRIDER SYSTEM

Applicant Stryker Ireland Ltd., Instruments Division

K number K073633

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ERL 2008-03-24

XPS 3000 SYSTEM

Applicant Medtronic Xomed, Inc.

K number K073255

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ERL 2005-12-19

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K053262

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ERL 2004-07-23

XPS 3000 SYSTEM

Applicant Medtronic Xomed, Inc.

K number K041523

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ERL 2004-07-12

XPS 3000 SYSTEM

Applicant Medtronic Xomed, Inc.

K number K041413

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ERL 2004-03-03

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)

Applicant Stryker Instruments

K number K040300

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ERL 2004-03-03

DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE

Applicant Gyrus Ent LLC

K number K034004

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ERL 2003-01-28

SODEM HIGH SPEED SYSTEM (PNEUMATIC)

Applicant Sodemsystems

K number K023070

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ERL 2002-12-03

DAUM-LECTRIC MRI DRILLING MACHINE

Applicant Mri Devices Daum GmbH

K number K021098

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ERL 2002-06-19

UNIDRIVE II PLUS DISPOSABLE TUBING SET

Applicant Mtp Medical Technical Promotion GmbH

K number K021811

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ERL 2002-03-08

DIEGO POWERED DISSECTOR AND DRILL SYSTEM

Applicant Gyrus Ent LLC

K number K020594

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ERL 2001-09-21

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

Applicant Sodemsystems

K number K012456

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ERL 2001-06-26

MODIFICATION TO XPS 3000 SYSTEM

Applicant Medtronic Xomed, Inc.

K number K011321

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ERL 2001-05-25

HUMMER IV MICRODEBRIDER SYSTEM

Applicant Stryker Instruments

K number K011381

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ERL 2001-04-13

KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K003994

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ERL 2000-12-04

XPS 3000 SYSTEM

Applicant Medtronic Xomed

K number K002224

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ERL 2000-10-17

XPS NITRO SYSTEM

Applicant Xomed, Inc.

K number K002828

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ERL 1999-11-23

TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;

Applicant Gyrus Ent LLC

K number K992994

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ERL 1999-02-19

HUMMER TRAK SYSTEM

Applicant Stryker Endoscopy

K number K990038

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ERL 1998-11-25

PNEUMATIC CUTTER SYSTEM

Applicant Surgical Laser Technologies, Inc.

K number K983050

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ERL 1998-10-21

XPS DRILL SYSTEM

Applicant Xomed, Inc.

K number K983224

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ERL 1998-08-27

SLT BIPOLAR SHEATH

Applicant Surgical Laser Technologies, Inc.

K number K981041

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ERL 1998-07-20

INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY

Applicant Linvatec Corp.

K number K981637

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ERL 1998-03-10

ULTRABUR

Applicant Mednet Locator, Inc.

K number K974174

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ERL 1997-11-05

POWERTREK INSTRUMENTS

Applicant Medtrek Corp.

K number K972057

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ERL 1997-10-01

STRYKER HUMMER II MICRODEBRIDER SYSTEM

Applicant Stryker Endoscopy

K number K972584

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ERL 1997-09-29

ENT IRRIGATING PUMP (70327700)

Applicant Gyrus Ent LLC

K number K973286

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ERL 1997-09-29

PROMEX ENT TISSUE REMOVAL SYSTEM

Applicant Promex, Inc.

K number K972865

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ERL 1997-09-05

XPS STRAIGHTSHOT MICRORESECTOR

Applicant Xomed, Inc.

K number K972453

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ERL 1997-04-09

MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)

Applicant Midas Rex Pneumatic Tools, Inc.

K number K970965

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ERL 1997-01-17

APEX UNIVERSAL DRIVE SYSTEM

Applicant Linvatec Corp.

K number K964548

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ERL 1997-01-10

ANSPACH MICROMAX SYSTEM

Applicant The Anspach Effort, Inc.

K number K965080

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ERL 1996-09-23

TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT

Applicant Medtronic Xomed

K number K963246

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ERL 1996-07-25

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL

Applicant Misten Medical Corp.

K number K962163

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ERL 1996-04-26

IRRIGATION SYSTEM

Applicant Linvatec Corp.

K number K961192

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ERL 1995-11-27

DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

Applicant Smith & Nephew Dyonics, Inc.

K number K954989

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ERL 1995-11-06

MICRO-INGRESSOR HANDIPIECE

Applicant Trebay Medical Corp.

K number K954796

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ERL 1995-10-27

MICRO-PLANER HANDPIECE

Applicant Trebay Medical Corp.

K number K954715

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ERL 1995-07-20

STRYKER HUMMER II MICRODEBRIDER SYSTEM

Applicant Stryker Endoscopy

K number K952681

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ERL 1995-04-17

INTRAARC DRIVE SYSTEM

Applicant Linvatec Corp.

K number K951263

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ERL 1995-03-24

KARL STORZ INTRA-HANDPIECES AND ACCESSORIES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K950964

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ERL 1995-01-09

BLACKSTAR(TM) STAR SYSTEM

Applicant Xomed-Treace, Inc.

K number K945659

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ERL 1995-01-09

STRYKER TOTAL PERFORMANCE SYSTEM

Applicant Stryker Corp.

K number K943569

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ERL 1994-11-22

EDI-BUR MICRODRILL SYSTEMS

Applicant Micromed Development Corp.

K number K945438

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ERL 1994-11-22

ELECTRIC SURGICAL DRILL

Applicant Alamo City Dental Supply Co.

K number K940016

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ERL 1994-11-18

APEX UNIVERSAL DRIVE SYSTEM

Applicant Linvatec Corp.

K number K944476

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ERL 1994-08-17

MEDNEXT MICRO-DRILL

Applicant Mednext, Inc.

K number K943108

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ERL 1994-05-16

STRYKER MICRODEBRIDER SYSTEM

Applicant Stryker Corp.

K number K940710

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ERL 1991-11-27

DRILL MODULES MODELS 2116/2117

Applicant Micro Surgical Instruments Corp.

K number K914346

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ERL 1991-04-22

X-T AIR DRILL

Applicant Xomed-Treace, Inc.

K number K905800

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ERL 1987-09-04

TREACE MAGNUM OTO-TOOL SYSTEM

Applicant Treace Medical, Inc.

K number K873154

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ERL 1986-08-15

TREACE DRILL SYSTEM

Applicant Treace Medical, Inc.

K number K862807

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ERL 1986-01-21

MICRO-AIRE STAPES DRILL SYSTEM

Applicant Micro-Aire Surgical Instruments, Inc.

K number K854332

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ERL 1986-01-21

MICRO-AIRE OTO/NEURO DRILL SYSTEM

Applicant Micro-Aire Surgical Instruments, Inc.

K number K854331

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ERL 1984-08-10

TISSUE INTEGRATED PROSTHESIS DRILL

Applicant Bofors Nobelpharma, Inc.

K number K841813

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ERL 1984-06-22

SHEA FOOTPLATE MICRODRILL

Applicant Applied Research Corp.

K number K833875

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ERL 1984-06-22

SHEA MIDDLE EAR MICRODRILL

Applicant Applied Research Corp.

K number K833874

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ERL 1983-11-03

SURGICAL DRILL-ELECTRIC-HANDPIECE

Applicant Entronics

K number K831946

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ERL 1982-08-12

TORX OR TYPE MICRO MOTOR HANDPIECE

Applicant Kelleher Corp.

K number K822008

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ERL 1980-10-31

MICRO-SURGICAL POWER INSTRUMENT SYSTEM

Applicant Spire Medical, Inc.

K number K802463

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ERL 1979-11-27

FISCH DRILL SYSTEM

Applicant Jedmed Instrument Co.

K number K792159

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ERL 1979-08-22

WOMED NICRO-CRAFT POWER SYSTEM

Applicant Xomed, Inc.

K number K791407

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ERL 1978-08-31

XOMED TRANSSPHENOIDAL HANDPIECE

Applicant Xomed, Inc.

K number K781418

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