Product code FFL
- Device name
- Dislodger, Stone, Basket, Ureteral, Metal
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4680
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K012581 | REPROCESSED STONE RETRIEVAL BASKETS | Sterilmed, Inc. | 2002-02-14 |
| 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 |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | Annex Medical, Inc. | 1994-02-25 |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | Surgitek | 1994-01-11 |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1994-01-07 |
| K930349 | STONE RETRIEVAL BASKET | Endomedix | 1993-06-09 |
| K924027 | DISLODGER, STONE, BASKET, URETERAL, METAL | Annex Medical, Inc. | 1992-10-20 |
| K922678 | LOOP RETRIEVER | Annex Medical, Inc. | 1992-08-25 |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Intramed Laboratories, Inc. | 1992-08-03 |
| K921233 | BARD 4-WIRE URETEROSCOPIC STONE | C.R. Bard, Inc. | 1992-04-27 |
| K914505 | STONE BASKET | Surgitek Medical Engineering Corp. | 1991-12-09 |
| K910603 | LOOP RETRIEVER | Annex Medical, Inc. | 1991-03-11 |
| K900269 | PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE | Porges Corp. | 1990-07-03 |
| K896992 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1990-02-08 |
| K896169 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | 1989-12-18 |
| K891254 | UROLOGICAL STONE BASKET | Northgate Research, Inc. | 1989-03-22 |
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| 08714729341864 | Segura Hemisphere | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729121299 | Escape | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729121282 | Escape | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729087441 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729087434 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729087427 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729087410 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729087403 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729087397 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729074311 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729074304 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729074281 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729043324 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069744 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069737 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069720 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069713 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069706 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069690 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069676 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069669 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729069652 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729057055 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729057031 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729049043 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729043379 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729043355 | Gemini | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |