System, Applicator, Radionuclide, Manual

FDA product code IWJ · 36 cleared devices

Class 1 Radiology

Regulation: 21 CFR 892.5650
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-03-25 – 2001-12-03

IWJ 2001-12-03

IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM

Applicant Imagyn Medical Technologies, Inc.

K number K010166

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IWJ 1998-09-28

PGK DEVICE (MODIFIED)

Applicant Pgk, Inc.

K number K980997

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IWJ 1998-02-17

REGANES RADIONUCLIDE SEED MAGAZINE

Applicant Avid N.I.T., Inc.

K number K972554

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IWJ 1998-01-27

N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000

Applicant Avid N.I.T., Inc.

K number K973037

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IWJ 1998-01-23

WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET

Applicant Worldwide Medical Technologies, LLC

K number K974118

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IWJ 1998-01-02

NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE

Applicant Nw Radiation Therapy Products

K number K973786

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IWJ 1997-12-23

N.I.T., INC. NEEDLE GUIDING TEMPLATE

Applicant Avid N.I.T., Inc.

K number K973638

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IWJ 1997-11-21

PROSTATE SEEDING NEEDLE

Applicant Promex, Inc.

K number K973184

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IWJ 1996-12-06

MANAN PROSTATE UNI-LOCK

Applicant Manan Medical Products, Inc.

K number K963743

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IWJ 1996-08-22

WEEKS APPLICATOR

Applicant Duke University Medical Center

K number K951052

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IWJ 1996-07-03

MANAN PROSTATE LOCKING INTRODUCER SET

Applicant Manan Medical Products, Inc.

K number K961377

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IWJ 1995-02-24

MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT

Applicant Medical Device Technologies, Inc.

K number K944522

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IWJ 1994-12-30

IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS

Applicant Best Industries

K number K940121

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IWJ 1994-12-30

IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES

Applicant Best Industries

K number K933410

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IWJ 1994-08-17

COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH

Applicant Cook, Inc.

K number K940550

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IWJ 1993-06-04

BEST INDUSTRIES CARTRIDGE & GUN

Applicant Best Industries

K number K924290

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IWJ 1992-10-13

QUICK SEEDER

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K913293

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IWJ 1992-10-05

NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE

Applicant Needle Technologies, Inc.

K number K921886

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IWJ 1992-07-01

SDMO APPLICATOR CODE: ASN.8236

Applicant Medi-Physics Inc. Dba Nycomed Amersham Imaging

K number K921961

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IWJ 1991-04-18

VARIOUS TEMPLATE APPLICATORS

Applicant Best Industries

K number K910862

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IWJ 1991-01-04

VARIOUS AFTERLOADING APPLICATORS

Applicant Best Assoc. Corp.

K number K904933

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IWJ 1990-10-01

CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR

Applicant University of Michigan

K number K903403

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IWJ 1990-07-11

PLASTIC-GUIDES

Applicant M & K Co.

K number K901842

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IWJ 1989-09-18

AFTER LOADING DEVICE KIT

Applicant Medical Radiation Devices, Inc.

K number K893703

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IWJ 1989-04-14

HILARIS-NORI CERVIX APPLICATOR

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K891377

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IWJ 1989-04-14

WANG FRONT LOADING APPLICATOR

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K890485

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IWJ 1989-03-14

MICK 200-TP AND MICK TP NEEDLE

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K890341

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IWJ 1989-02-06

HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN

Applicant Amersham Corp.

K number K890191

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IWJ 1987-07-21

HILARIS-NORI ENDOMETRIAL APPLICATOR

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K871216

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IWJ 1987-07-16

HENSCHKE AFTERLOADING APPLICATOR

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K871217

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IWJ 1987-07-16

KUMAR CERVICAL APPLICATOR

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K871213

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IWJ 1985-03-26

I-125 IMPLANT GUN

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K850571

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IWJ 1983-09-29

HEYER-SCHULTE AFTERLOADING CATHETER

Applicant American Heyer Schulte

K number K832738

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IWJ 1981-12-29

AFTERLOADING GYNECOLOGICAL APPLICATOR

Applicant Esi

K number K813230

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IWJ 1980-10-23

SCOTT NEEDLE & SCOTT MICK IMPLANTER

Applicant Mick Radio-Nuclear Instruments, Inc.

K number K801983

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IWJ 1980-03-25

CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.

Applicant Amersham Corp.

K number K800320

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