Product code IWJ
- Device name
- System, Applicator, Radionuclide, Manual
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.5650
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010166 | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM | Imagyn Medical Technologies, Inc. | 2001-12-03 |
| K980997 | PGK DEVICE (MODIFIED) | Pgk, Inc. | 1998-09-28 |
| K972554 | REGANES RADIONUCLIDE SEED MAGAZINE | Avid N.I.T., Inc. | 1998-02-17 |
| K973037 | N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 | Avid N.I.T., Inc. | 1998-01-27 |
| K974118 | WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET | Worldwide Medical Technologies, LLC | 1998-01-23 |
| K973786 | NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE | Nw Radiation Therapy Products | 1998-01-02 |
| K973638 | N.I.T., INC. NEEDLE GUIDING TEMPLATE | Avid N.I.T., Inc. | 1997-12-23 |
| K973184 | PROSTATE SEEDING NEEDLE | Promex, Inc. | 1997-11-21 |
| K963743 | MANAN PROSTATE UNI-LOCK | Manan Medical Products, Inc. | 1996-12-06 |
| K951052 | WEEKS APPLICATOR | Duke University Medical Center | 1996-08-22 |
| K961377 | MANAN PROSTATE LOCKING INTRODUCER SET | Manan Medical Products, Inc. | 1996-07-03 |
| K944522 | MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT | Medical Device Technologies, Inc. | 1995-02-24 |
| K940121 | IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS | Best Industries | 1994-12-30 |
| K933410 | IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES | Best Industries | 1994-12-30 |
| K940550 | COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH | Cook, Inc. | 1994-08-17 |
| K924290 | BEST INDUSTRIES CARTRIDGE & GUN | Best Industries | 1993-06-04 |
| K913293 | QUICK SEEDER | Mick Radio-Nuclear Instruments, Inc. | 1992-10-13 |
| K921886 | NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE | Needle Technologies, Inc. | 1992-10-05 |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1992-07-01 |
| K910862 | VARIOUS TEMPLATE APPLICATORS | Best Industries | 1991-04-18 |
| K904933 | VARIOUS AFTERLOADING APPLICATORS | Best Assoc. Corp. | 1991-01-04 |
| K903403 | CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR | University of Michigan | 1990-10-01 |
| K901842 | PLASTIC-GUIDES | M & K Co. | 1990-07-11 |
| K893703 | AFTER LOADING DEVICE KIT | Medical Radiation Devices, Inc. | 1989-09-18 |
| K891377 | HILARIS-NORI CERVIX APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1989-04-14 |
| K890485 | WANG FRONT LOADING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1989-04-14 |
| K890341 | MICK 200-TP AND MICK TP NEEDLE | Mick Radio-Nuclear Instruments, Inc. | 1989-03-14 |
| K890191 | HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN | Amersham Corp. | 1989-02-06 |
| K871216 | HILARIS-NORI ENDOMETRIAL APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1987-07-21 |
| K871217 | HENSCHKE AFTERLOADING APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | 1987-07-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B1655635032805302533 | Implant Needle | Liberty Medical , Inc. | 2026-06-01 |
| B16556330328053126035 | Flexi-Needle | Liberty Medical , Inc. | 2026-06-01 |
| B16570940328053126107 | Adapter | Liberty Medical , Inc. | 2026-06-01 |
| B16570170328053126102 | Flexi-Needle | Liberty Medical , Inc. | 2026-06-01 |
| B16570160328053126101 | Flexi-Needle | Liberty Medical , Inc. | 2026-06-01 |
| B16559100328053026079 | Buttons | Liberty Medical , Inc. | 2026-06-01 |
| B16559090328053026060 | Buttons | Liberty Medical , Inc. | 2026-06-01 |
| B16559060328053026074 | Buttons | Liberty Medical , Inc. | 2026-06-01 |
| B16559050328053126091 | Buttons | Liberty Medical , Inc. | 2026-06-01 |
| B16558110328022826066 | Medium Prostate Brachytherapy Kit-metal hub | Liberty Medical , Inc. | 2026-06-01 |
| B165580203270931260031 | Large Prostate Brachytherapy Kit | Liberty Medical , Inc. | 2026-06-01 |
| B16558010328010026067 | Medium Prostate Brachytherapy Kit | Liberty Medical , Inc. | 2026-06-01 |
| B16558010327123126103 | Medium Prostate Brachytherapy Kit | Liberty Medical , Inc. | 2026-06-01 |
| B1655662032805302615 | Intrauterine Tandem | Liberty Medical , Inc. | 2026-06-01 |
| 00841365121579 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2026-05-29 |
| B16556320328033123181 | Flexi-Needle | Liberty Medical , Inc. | 2026-03-26 |
| B16556410327103125201 | Single Leader Catheter with Button | Liberty Medical , Inc. | 2025-11-10 |
| B16556320327103125206 | Flexi-Needle | Liberty Medical , Inc. | 2025-11-10 |
| B16556210327103125202 | Implant Needle | Liberty Medical , Inc. | 2025-11-10 |
| 00850014612061 | SIR-Spheres V-Vial | Sirtex Medical Inc. | 2021-07-15 |
| 00850014612092 | SIR-Spheres Accessories Pack | Sirtex Medical Inc. | 2021-07-14 |
| 00850014612054 | SIR-Spheres Delivery Set | Sirtex Medical Inc. | 2021-07-14 |
| 00850014612023 | SIROS Delivery Set | Sirtex Medical Inc. | 2021-01-05 |
| 10801741075947 | BrachyStar™ | Bard Brachytherapy, Inc. | 2020-09-22 |
| 10801741075961 | BrachyStar™ | Bard Brachytherapy, Inc. | 2020-09-22 |
| 10801741075923 | BrachyStar™ | Bard Brachytherapy, Inc. | 2020-09-21 |
| 10801741124119 | BrachyStar™, FastFill™ | Bard Brachytherapy, Inc. | 2020-09-21 |
| 10841436104354 | Template Grid | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 10841436104361 | Template Grid | CIVCO MEDICAL INSTRUMENTS CO., INC. | 2017-08-22 |
| 10801741078122 | QuickLink™ | Bard Brachytherapy, Inc. | 2015-10-05 |