Data / Medical devices / United States / Mick Radio-Nuclear Instruments, Inc.
Mick Radio-Nuclear Instruments, Inc.: FDA-registered device maker in Mount Vernon, NY, United States, 28 510(k) clearances
Mick Radio-Nuclear Instruments, Inc. is registered with the FDA (registration 2431392) in Mount Vernon, NY, United States. It lists 4 device types. The FDA files 28 510(k) clearances under its listings, the newest dated August 30, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2431392
- Address
- 521 Homestead Ave., Mount Vernon, NY, United States, 10550
- Owner or operator
- Mick Radio-Nuclear Instruments, Inc. (10045775)
- Roles
- Manufacturer
- First device listed
- December 26, 2013
- Registered through
- 2026
- Brand names listed
- CT Compatible Intrauterine Sleeves, CT HDR Tandem / Ring Applicator, CT/MR Compatible Contour Template, Graticule, H.A.M Applicator, HDR CT Compatible F/S/D Applicator, HDR CT Compatible Ring & Tandem Applicator w/ 2 Piece Rectal Retractor, HDR CT Compatible Split Ring Applicator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Nuclear | IYP | 1 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 30, 2023 | K230155 | Mick Valencia Applicator Set | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| May 31, 2016 | K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| February 19, 2015 | K142597 | Vienna System | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| December 14, 2012 | K122840 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| December 26, 2006 | K063382 | HDR CT COMPATIBLE SPLIT RING APPLICATOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| December 22, 2006 | K063381 | CT COMPATIBLE F/S/D APPLICATORS | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| October 17, 2005 | K052351 | HDR IORT SHIELDED APPLICATOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| July 1, 2005 | K051423 | MICK HDR INTERSTITIAL IMPLANT ACCESSORIES | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| June 18, 2004 | K040704 | MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| February 2, 2004 | K033828 | CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| April 3, 2003 | K030110 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| April 8, 2002 | K020176 | HDR MIAMI APPLICATOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| August 27, 2001 | K011657 | HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| November 17, 2000 | K001544 | VAGINAL APPLICATOR SHIELDED | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| February 14, 2000 | K993960 | PERMA-DOC PHANTOM | IYE | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| February 14, 2000 | K993959 | ISOCENTRIC BEAM CHECKER | IYE | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| January 12, 2000 | K993472 | SEGMENTED VAGINAL APPLICATOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| January 6, 2000 | K993400 | HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| June 29, 1999 | K991107 | SHADOW TRAYS | IYE | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| October 16, 1997 | K972709 | TBI STAND | IYE | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| December 23, 1996 | K961601 | H.A.M. APPLICATOR | JAQ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| April 14, 1989 | K891377 | HILARIS-NORI CERVIX APPLICATOR | IWJ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| April 14, 1989 | K890485 | WANG FRONT LOADING APPLICATOR | IWJ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| March 14, 1989 | K890341 | MICK 200-TP AND MICK TP NEEDLE | IWJ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| July 21, 1987 | K871216 | HILARIS-NORI ENDOMETRIAL APPLICATOR | IWJ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| July 16, 1987 | K871217 | HENSCHKE AFTERLOADING APPLICATOR | IWJ | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| May 8, 1987 | K871214 | GRATICULE | IYE | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
| December 8, 1981 | K812893 | SUPERFLAB | IYP | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 30, 2005 | 32046 | Not yet classified | Terminated | Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclid | Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator. Firm received one complaint during use of the Mick 200 TPV Applicator. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Applicator, Radionuclide, Remote-Controlled
- All makers of System, Applicator, Radionuclide, Manual
- All makers of Accelerator, Linear, Medical
- All makers of Phantom, Anthropomorphic, Nuclear
Updated August 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.