Mick Radio-Nuclear Instruments, Inc.
Mount Vernon, NY, US
MICK RADIO-NUCLEAR INSTRUMENTS, INC. appears in FDA device records in Mount Vernon, NY. FDA records list 43 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Mick Radio-Nuclear Instruments, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Mick Radio Nuclear Instr Increcall
510(k) clearance history
FDA records hold 43 510(k) clearances for Mick Radio-Nuclear Instruments, Inc. between 1978 and 2023. The busiest year on record is 1987, with 5. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1980 | 2 |
| 1981 | 4 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1987 | 5 |
| 1989 | 5 |
| 1992 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 5 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230155 | Mick Valencia Applicator Set | JAQ | Substantially Equivalent | |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor | JAQ | Substantially Equivalent | |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | JAQ | Substantially Equivalent | |
| K142597 | Vienna System | JAQ | Substantially Equivalent | |
| K122840 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 | JAQ | Substantially Equivalent | |
| K063382 | HDR CT COMPATIBLE SPLIT RING APPLICATOR | JAQ | Substantially Equivalent | |
| K063381 | CT COMPATIBLE F/S/D APPLICATORS | JAQ | Substantially Equivalent | |
| K052351 | HDR IORT SHIELDED APPLICATOR | JAQ | Substantially Equivalent | |
| K051423 | MICK HDR INTERSTITIAL IMPLANT ACCESSORIES | JAQ | Substantially Equivalent | |
| K040704 | MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR | JAQ | Substantially Equivalent | |
| K033828 | CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 | JAQ | Substantially Equivalent | |
| K030110 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | JAQ | Substantially Equivalent | |
| K020176 | HDR MIAMI APPLICATOR | JAQ | Substantially Equivalent | |
| K011657 | HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR | JAQ | Substantially Equivalent | |
| K001544 | VAGINAL APPLICATOR SHIELDED | JAQ | Substantially Equivalent | |
| K993960 | PERMA-DOC PHANTOM | IYE | Substantially Equivalent | |
| K993959 | ISOCENTRIC BEAM CHECKER | IYE | Substantially Equivalent | |
| K993472 | SEGMENTED VAGINAL APPLICATOR | JAQ | Substantially Equivalent | |
| K993400 | HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES | JAQ | Substantially Equivalent | |
| K991107 | SHADOW TRAYS | IYE | Substantially Equivalent | |
| K972709 | TBI STAND | IYE | Substantially Equivalent | |
| K961601 | H.A.M. APPLICATOR | JAQ | Substantially Equivalent | |
| K913293 | QUICK SEEDER | IWJ | Substantially Equivalent | |
| K894381 | GAMMAMED IRIDIUM-192 SOURCE | JAQ | Substantially Equivalent | |
| K891131 | GAMMAMED 12I | JAQ | Substantially Equivalent | |
| K891377 | HILARIS-NORI CERVIX APPLICATOR | IWJ | Substantially Equivalent | |
| K890485 | WANG FRONT LOADING APPLICATOR | IWJ | Substantially Equivalent | |
| K890341 | MICK 200-TP AND MICK TP NEEDLE | IWJ | Substantially Equivalent | |
| K871216 | HILARIS-NORI ENDOMETRIAL APPLICATOR | IWJ | Substantially Equivalent | |
| K871217 | HENSCHKE AFTERLOADING APPLICATOR | IWJ | Substantially Equivalent | |
| K871213 | KUMAR CERVICAL APPLICATOR | IWJ | Substantially Equivalent | |
| K871214 | GRATICULE | IYE | Substantially Equivalent | |
| K871215 | DISPOSABLE SHADOW TRAY INSERTS | IWB | Substantially Equivalent | |
| K850571 | I-125 IMPLANT GUN | IWJ | Substantially Equivalent | |
| K834308 | MULTITREAT 48 | JAQ | Substantially Equivalent | |
| K837344 | BEAM BLOCK SHAPER | Substantially Equivalent | ||
| K812893 | SUPERFLAB | IYP | Substantially Equivalent | |
| K811279 | AFTERLOADING CATHETER SET | Substantially Equivalent | ||
| K811280 | FLEX-TEMPLATE | KDC | Substantially Equivalent | |
| K811278 | EXTENDED TUMOR CALIPER | FTY | Substantially Equivalent | |
| K802032 | MINI MICK APPLICATOR | JWJ | Substantially Equivalent | |
| K801983 | SCOTT NEEDLE & SCOTT MICK IMPLANTER | IWJ | Substantially Equivalent | |
| K781274 | GAMMA MED II | JAQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431392 | 2431392 | MICK RADIO-NUCLEAR INSTRUMENTS, INC. | 521 HOMESTEAD AVE., MOUNT VERNON, NY 10550 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- KDCInstrument, Surgical, Disposable
- IYPPhantom, Anthropomorphic, Nuclear
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- IWJSystem, Applicator, Radionuclide, Manual
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- IWBSystem, Radiation Therapy, Radionuclide
- FTYTape, Measuring, Rulers And Calipers
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0857-05 | 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, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each. | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain