System, Applicator, Radionuclide, Manual
FDA product code IWJ · Class I (low risk) · 21 CFR 892.5650 · Radiology
36510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Mick Radio-Nuclear Instruments, Inc. 9
- Best Industries 4
- Avid N.I.T., Inc. 3
- Amersham Corp. 2
- Manan Medical Products, Inc. 2
- Imagyn Medical Technologies, Inc. 1
- Pgk, Inc. 1
- Worldwide Medical Technologies, LLC 1
- Nw Radiation Therapy Products 1
- Promex, Inc. 1
- Duke University Medical Center 1
- Medical Device Technologies, Inc. 1
- Cook, Inc. 1
- Needle Technologies, Inc. 1
- Medi-Physics Inc. Dba Nycomed Amersham Imaging 1
- Best Assoc. Corp. 1
- University of Michigan 1
- M & K Co. 1
- Medical Radiation Devices, Inc. 1
- American Heyer Schulte 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010166 | Imagyn Isosleeve / Isostar Needle SystemIWJ · Traditional | Imagyn Medical Technologies, Inc. | 12/03/2001SE |
| K980997 | PGK Device (Modified)IWJ · Traditional | Pgk, Inc. | 09/28/1998SE |
| K972554 | Reganes Radionuclide Seed MagazineIWJ · Traditional | Avid N.I.T., Inc. | 02/17/1998SE |
| K973037 | N.I.T., Inc. Radionuclide Seed Applicator, Model SA-1000IWJ · Traditional | Avid N.I.T., Inc. | 01/27/1998SE |
| K974118 | Worldwide Medical Technologies Seed Implant Needle SetIWJ · Traditional | Worldwide Medical Technologies, LLC | 01/23/1998SE |
| K973786 | Northwest Radiation Therapy Products, Precision Stepper and GuideIWJ · Traditional | Nw Radiation Therapy Products | 01/02/1998SE |
| K973638 | N.I.T., Inc. Needle Guiding TemplateIWJ · Traditional | Avid N.I.T., Inc. | 12/23/1997SE |
| K973184 | Prostate Seeding NeedleIWJ · Traditional | Promex, Inc. | 11/21/1997SE |
| K963743 | Manan Prostate Uni-LockIWJ · Traditional | Manan Medical Products, Inc. | 12/06/1996SE |
| K951052 | Weeks ApplicatorIWJ · Traditional | Duke University Medical Center | 08/22/1996SE |
| K961377 | Manan Prostate Locking Introducer SetIWJ · Traditional | Manan Medical Products, Inc. | 07/03/1996SE |
| K944522 | Morganstern Prostate Stabilization and Seeding KitIWJ · Traditional | Medical Device Technologies, Inc. | 02/24/1995SE |
| K940121 | Implanters/Adjustable/Anderson's MarkersIWJ · Traditional | Best Industries | 12/30/1994SE |
| K933410 | Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of…IWJ · Traditional | Best Industries | 12/30/1994SE |
| K940550 | Cook Brach Needle/Radio Deliv Cath/Flexi FlexicathIWJ · Traditional | Cook, Inc. | 08/17/1994SE |
| K924290 | Best Industries Cartridge & GunIWJ · Traditional | Best Industries | 06/04/1993SE |
| K913293 | Quick SeederIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 10/13/1992SE |
| K921886 | Needle Technologies Seed Implant NeedleIWJ · Traditional | Needle Technologies, Inc. | 10/05/1992SE |
| K921961 | Sdmo Applicator Code: ASN.8236IWJ · Traditional | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 07/01/1992SE |
| K910862 | Various Template ApplicatorsIWJ · Traditional | Best Industries | 04/18/1991SE |
| K904933 | Various Afterloading ApplicatorsIWJ · Traditional | Best Assoc. Corp. | 01/04/1991SE |
| K903403 | Ct-Compatible Fletcher System ApplicatorIWJ · Traditional | University of Michigan | 10/01/1990SE |
| K901842 | Plastic-GuidesIWJ · Traditional | M & K Co. | 07/11/1990SE |
| K893703 | After Loading Device KitIWJ · Traditional | Medical Radiation Devices, Inc. | 09/18/1989SE |
| K891377 | Hilaris-Nori Cervix ApplicatorIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 04/14/1989SE |
| K890485 | Wang Front Loading ApplicatorIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 04/14/1989SE |
| K890341 | Mick 200-TP and Mick TP NeedleIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 03/14/1989SE |
| K890191 | Handling & Cutting Device for IRIDIUM-192 Wire PinIWJ · Traditional | Amersham Corp. | 02/06/1989SE |
| K871216 | Hilaris-Nori Endometrial ApplicatorIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 07/21/1987SE |
| K871217 | Henschke Afterloading ApplicatorIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 07/16/1987SE |
| K871213 | Kumar Cervical ApplicatorIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 07/16/1987SE |
| K850571 | I-125 Implant GunIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 03/26/1985SE |
| K832738 | Heyer-Schulte Afterloading CatheterIWJ · Traditional | American Heyer Schulte | 09/29/1983SE |
| K813230 | Afterloading Gynecological ApplicatorIWJ · Traditional | Esi | 12/29/1981SE |
| K801983 | Scott Needle & Scott Mick ImplanterIWJ · Traditional | Mick Radio-Nuclear Instruments, Inc. | 10/23/1980SE |
| K800320 | CESIUM-137 Afterloading System /Gyn.Bra.IWJ · Traditional | Amersham Corp. | 03/25/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1275-2021 Class II | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.There is a potential presence of particulate matter in the D-Vial. | Sirtex Medical Limited | 02/22/2021Terminated |
| Z-0795-2020 Class II | Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on…The integrity of the sterile grid packaging is potentially compromised. | Riverpoint Medical, LLC | 02/08/2019Terminated |
| Z-0643-2019 Class II | Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements…Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed | Theragenics Corporation | 10/09/2018Terminated |
| Z-0777-2019 Class III | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The…Product is labeled with "CE", but is not yet approved in the European Union. | Riverpoint Medical, LLC | 01/09/2018Terminated |
| Z-0040-2012 | Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with…Length of the cannula hub is longer and may not permit a fit with the Applicator | Worldwide Medical Technologies, LLC | 08/12/2011Terminated |
| Z-2022-2010 | Angiotech Prostate Stabilization Set. Prostate Stabilization Set. STERILE. Product…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | Medical Device Technologies, Inc. | 09/01/2009Terminated |
| Z-0170-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-010 Description: FLEXIGUIDE NEEDLE…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | Alpha Omega Services Inc | 11/15/2007Terminated |
| Z-0169-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | Alpha Omega Services Inc | 11/15/2007Terminated |
| Z-0168-2009 | Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | Alpha Omega Services Inc | 11/15/2007Terminated |
| Z-0167-2009 | Alpha-Omega Services, Inc. Product No: NFV0003-003 Description: NEEDLE, FLEXIGUIDE:…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | Alpha Omega Services Inc | 11/15/2007Terminated |
| Z-0166-2009 | Alpha-Omega Services, Inc. Product No: NFV0001-004 Description: NEEDLE, FLEXIGUIDE:…There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles… | Alpha Omega Services Inc | 11/15/2007Terminated |