FDA Product Code
FDA Product Code FFL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4680
510(k) Clearances — 52 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190492 | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | 2019-07-18 | Traditional | PDF ↗ |
| K172299 | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | 2017-09-19 | Special | PDF ↗ |
| K102887 | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | Percutaneous Systems, Inc. | 2011-05-16 | Traditional | PDF ↗ |
| K082803 | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 | Percutaneous Systems, Inc. | 2008-11-13 | Traditional | PDF ↗ |
| K052048 | ACCORDION | Percutaneous Systems, Incorporated | 2005-09-13 | Traditional | PDF ↗ |
| K012581 | REPROCESSED STONE RETRIEVAL BASKETS | Sterilmed, Inc. | 2002-02-14 | Traditional | PDF ↗ |
| K972091 | AMS FOREIGN BODY EXTRATOR | American Medical Systems, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K970489 | COMEG ENDOSCOPY GRASPING FORCEPS | Comeg Endoscopy | 1997-03-19 | Traditional | PDF ↗ |
| K962387 | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) | Olympus America, Inc. | 1996-07-31 | Traditional | PDF ↗ |
| K961248 | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS | C.R. Bard, Inc. | 1996-05-28 | Traditional | PDF ↗ |
| K955049 | OLYMPUS FG-45/46-1 GRASPING FORCEPS | Olympus America, Inc. | 1995-12-15 | Traditional | PDF ↗ |
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | Annex Medical, Inc. | 1995-10-26 | Traditional | PDF ↗ |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K935737 | STONE EXTRACTOR, GRASPING FORCEPS | Boston Scientific Corp | 1994-09-07 | Traditional | PDF ↗ |
| K935721 | STONE EXTRACTOR | Boston Scientific Corp | 1994-08-22 | Traditional | PDF ↗ |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | Annex Medical, Inc. | 1994-02-25 | Traditional | PDF ↗ |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | Surgitek | 1994-01-11 | Traditional | PDF ↗ |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K930349 | STONE RETRIEVAL BASKET | Endomedix | 1993-06-09 | Traditional | PDF ↗ |
| K924027 | DISLODGER, STONE, BASKET, URETERAL, METAL | Annex Medical, Inc. | 1992-10-20 | Traditional | PDF ↗ |
| K922678 | LOOP RETRIEVER | Annex Medical, Inc. | 1992-08-25 | Traditional | PDF ↗ |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Intramed Laboratories, Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K921233 | BARD 4-WIRE URETEROSCOPIC STONE | C.R. Bard, Inc. | 1992-04-27 | Traditional | PDF ↗ |
| K914505 | STONE BASKET | Surgitek Medical Engineering Corp. | 1991-12-09 | Traditional | PDF ↗ |
| K910603 | LOOP RETRIEVER | Annex Medical, Inc. | 1991-03-11 | Traditional | PDF ↗ |
| K900269 | PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE | Porges Corp. | 1990-07-03 | Traditional | PDF ↗ |
| K896992 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1990-02-08 | Traditional | PDF ↗ |
| K896169 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1989-12-18 | Traditional | PDF ↗ |
| K891254 | UROLOGICAL STONE BASKET | Northgate Research, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K884738 | CANDELA STONE BASKETS | Candela Laser Corp. | 1989-02-09 | Traditional | PDF ↗ |
| K871779 | HELICAL STONE BASKET (DISPOSABLE) | Van-Tec, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K871777 | VAN-TEC REUSABLE HELICAL STONE BASKET | Van-Tec, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K870696 | VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH | Van-Tec, Inc. | 1987-03-30 | Traditional | PDF ↗ |
| K870615 | VAN-TEC POSITIVE OPEN SEGURA BASKET | Van-Tec, Inc. | 1987-03-25 | Traditional | PDF ↗ |
| K864874 | SEGURA DRETLER BASKET | Van-Tec, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K863081 | 4-WIRE (CARSON) STONE EXTRACTOR | Cook Urological, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K862729 | PENN 3-RING HANDLE | Penn Medical Devices, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K861469 | DUTHOY STONE BASKET | Lake Region Mfg., Inc. | 1986-05-15 | Traditional | PDF ↗ |
| K860946 | DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER | Van-Tec, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K860268 | VAN-TEC DEFLECTING GRASPING FORCEPS | Van-Tec, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K860269 | VAN-TEC DEFLECTING LOOP RETRIEVER | Van-Tec, Inc. | 1986-03-25 | Traditional | PDF ↗ |
| K860270 | VAN-TEC DEFLECTING ROTATING SEGURA BASKET | Van-Tec, Inc. | 1986-03-25 | Traditional | PDF ↗ |
| K854652 | ANGIOMED URETERAL STONE DISLODGERS | Angiomed U.S., Inc. | 1986-02-10 | Traditional | PDF ↗ |
| K851922 | URETERAL STONE DISLODGER | Inter-Med Corp. | 1985-08-02 | Traditional | PDF ↗ |
| K851965 | WILSON-COOK STONE EXTRACTOR | Wilson-Cook Medical, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K850954 | URETERAL DILATOR & URETERAL STONE DISLODGER | American Edwards Laboratories | 1985-04-03 | Traditional | PDF ↗ |
| K841942 | SEGURA BASKET | Van-Tec, Inc. | 1984-07-19 | Traditional | PDF ↗ |
| K831875 | BALLOON DILATION HELICAL STONE EXTRACT | Vpi | 1983-09-12 | Traditional | PDF ↗ |
| K811580 | GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET | Porges Catheter Corp. | 1981-06-26 | Traditional | PDF ↗ |
| K800608 | STONE DISLODGER | G.D. Searle and Co. | 1980-04-08 | Traditional | PDF ↗ |
| K792344 | STONE AND RETRIEVAL BASKET | Mill-Rose Laboratory | 1979-12-20 | Traditional | PDF ↗ |
Product code FFL · Class II · Gastroenterology, Urology. Data: openFDA.