510(k) K012581
- Device
- REPROCESSED STONE RETRIEVAL BASKETS
- Applicant
- STERILMED, INC.
- 510(k) number
- K012581
- Product code
- FFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-14
- Date received
- 2001-08-09
- Regulation
- 876.4680
- Classification name
- Dislodger, Stone, Basket, Ureteral, Metal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK FLEISCHHACKER
- Address
- 11400 73rd Ave. N Suite 100 Maple Grove MN US 55369 55369
FDA Registration Numbers#
- 3011193403
- 3012649202
- 3010138349
- 1825146
- 3030447506
- 1018233
- 9610617
- 3043337628
- 8010047
- 3017103427
- 1061124
- 2183873
- 3017425975
- 3014615697
- 3007156625
- 2640138
- 9610711
- 1000121056
- 3008048800
- 3010400865
- 3020746799
- 8010418
- 3010399422
- 3012797688
- 3032436880
- 2124215
- 3004083736
- 3013530345
- 3002504068
- 3031158
- 3016931915
- 9681442
- 3023460764
- 3009039068
- 1928237
- 3021023752
- 3011050570
- 1313046
- 3010273872
- 1820334
- 3007695959
- 3030511423
- 3009607734
- 3018116884
- 3007738736
- 3030504644
- 3014769442
- 3010303097
- 3030733800
- 3006174295
- 3004365956
- 3005465238
- 1058584
- 1037905
- 3038296436
- 3013557562
- 3008808042
- 3011137372
- 3010202439
- 3002807314
- 9617744
- 1651252
- 3007055279
- 3007092328
- 1644312
- 3005987240
- 3011707784
- 1319660
- 1828132
- 9611590
- 3014279513
- 3008797804
- 9612074
- 3006082230
- 3017262662
- 3004134316
- 3022764278
- 3003289691
- 3016096097
- 3008573567
Source Documents#
Other 510(k) Records For Product Code FFL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190492 | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | 2019-07-18 |
| K172299 | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | 2017-09-19 |
| K102887 | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | Percutaneous Systems, Inc. | 2011-05-16 |
| K082803 | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 | Percutaneous Systems, Inc. | 2008-11-13 |
| K052048 | ACCORDION | Percutaneous Systems, Incorporated | 2005-09-13 |
| K972091 | AMS FOREIGN BODY EXTRATOR | American Medical Systems, Inc. | 1997-08-29 |
| K970489 | COMEG ENDOSCOPY GRASPING FORCEPS | Comeg Endoscopy | 1997-03-19 |
| K962387 | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) | Olympus America, Inc. | 1996-07-31 |
| K961248 | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS | C.R. Bard, Inc. | 1996-05-28 |
| K955049 | OLYMPUS FG-45/46-1 GRASPING FORCEPS | Olympus America, Inc. | 1995-12-15 |
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | Annex Medical, Inc. | 1995-10-26 |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1995-07-19 |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1995-05-11 |
| K935737 | STONE EXTRACTOR, GRASPING FORCEPS | Boston Scientific Corp | 1994-09-07 |
| K935721 | STONE EXTRACTOR | Boston Scientific Corp | 1994-08-22 |
Legacy Summary#
summary
FDA Review#
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