FDA Product Code
FDA Product Code IWJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5650
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K010166 | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM | Imagyn Medical Technologies, Inc. | 2001-12-03 | Traditional | PDF ↗ |
| K980997 | PGK DEVICE (MODIFIED) | Pgk, Inc. | 1998-09-28 | Traditional | PDF ↗ |
| K972554 | REGANES RADIONUCLIDE SEED MAGAZINE | Avid N.I.T., Inc. | 1998-02-17 | Traditional | PDF ↗ |
| K973037 | N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 | Avid N.I.T., Inc. | 1998-01-27 | Traditional | PDF ↗ |
| K974118 | WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET | Worldwide Medical Technologies, LLC | 1998-01-23 | Traditional | PDF ↗ |
| K973786 | NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE | Nw Radiation Therapy Products | 1998-01-02 | Traditional | PDF ↗ |
| K973638 | N.I.T., INC. NEEDLE GUIDING TEMPLATE | Avid N.I.T., Inc. | 1997-12-23 | Traditional | PDF ↗ |
| K973184 | PROSTATE SEEDING NEEDLE | Promex, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K963743 | MANAN PROSTATE UNI-LOCK | Manan Medical Products, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K951052 | WEEKS APPLICATOR | Duke University Medical Center | 1996-08-22 | Traditional | PDF ↗ |
| K961377 | MANAN PROSTATE LOCKING INTRODUCER SET | Manan Medical Products, Inc. | 1996-07-03 | Traditional | PDF ↗ |
| K944522 | MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT | Medical Device Technologies, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K940121 | IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS | Best Industries | 1994-12-30 | Traditional | PDF ↗ |
| K933410 | IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES | Best Industries | 1994-12-30 | Traditional | PDF ↗ |
| K940550 | COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH | Cook, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K924290 | BEST INDUSTRIES CARTRIDGE & GUN | Best Industries | 1993-06-04 | Traditional | PDF ↗ |
| K913293 | QUICK SEEDER | Mick Radio-Nuclear Instruments, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K921886 | NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE | Needle Technologies, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1992-07-01 | Traditional | PDF ↗ |
| K910862 | VARIOUS TEMPLATE APPLICATORS | Best Industries | 1991-04-18 | Traditional | PDF ↗ |
| K904933 | VARIOUS AFTERLOADING APPLICATORS | Best Assoc. Corp. | 1991-01-04 | Traditional | PDF ↗ |
| K903403 | CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR | University of Michigan | 1990-10-01 | Traditional | PDF ↗ |
| K901842 | PLASTIC-GUIDES | M & K Co. | 1990-07-11 | Traditional | PDF ↗ |
| K893703 | AFTER LOADING DEVICE KIT | Medical Radiation Devices, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K890485 | WANG FRONT LOADING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K891377 | HILARIS-NORI CERVIX APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K890341 | MICK 200-TP AND MICK TP NEEDLE | Mick Radio-Nuclear Instruments, Inc. | 1989-03-14 | Traditional | PDF ↗ |
| K890191 | HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN | Amersham Corp. | 1989-02-06 | Traditional | PDF ↗ |
| K871216 | HILARIS-NORI ENDOMETRIAL APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K871217 | HENSCHKE AFTERLOADING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1987-07-16 | Traditional | PDF ↗ |
| K871213 | KUMAR CERVICAL APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1987-07-16 | Traditional | PDF ↗ |
| K850571 | I-125 IMPLANT GUN | Mick Radio-Nuclear Instruments, Inc. | 1985-03-26 | Traditional | PDF ↗ |
| K832738 | HEYER-SCHULTE AFTERLOADING CATHETER | American Heyer Schulte | 1983-09-29 | Traditional | PDF ↗ |
| K813230 | AFTERLOADING GYNECOLOGICAL APPLICATOR | Esi | 1981-12-29 | Traditional | PDF ↗ |
| K801983 | SCOTT NEEDLE & SCOTT MICK IMPLANTER | Mick Radio-Nuclear Instruments, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K800320 | CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. | Amersham Corp. | 1980-03-25 | Traditional | PDF ↗ |
Product code IWJ · Class I · Radiology. Data: openFDA.