FFL — Dislodger, Stone, Basket, Ureteral, Metal Class II
FDA product code FFL covers "Dislodger, Stone, Basket, Ureteral, Metal", a Class II medical device regulated under 21 CFR 876.4680. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FFL
- Device Class
- Class II
- Regulation Number
- 876.4680
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190492 | calcula technologies | Peralta Stone Removal Catheter | July 18, 2019 |
| K172299 | ths international, inc. d/b/a accordion medical | Accordion Piccolo Stone Management Device | September 19, 2017 |
| K102887 | percutaneous systems | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | May 16, 2011 |
| K082803 | percutaneous systems | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 | November 13, 2008 |
| K052048 | percutaneous systems, incorporated | ACCORDION | September 13, 2005 |
| K012581 | sterilmed | REPROCESSED STONE RETRIEVAL BASKETS | February 14, 2002 |
| K972091 | american medical systems | AMS FOREIGN BODY EXTRATOR | August 29, 1997 |
| K970489 | comeg endoscopy | COMEG ENDOSCOPY GRASPING FORCEPS | March 19, 1997 |
| K962387 | olympus america | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) | July 31, 1996 |
| K961248 | c.r. bard | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BA | May 28, 1996 |
| K955049 | olympus america | OLYMPUS FG-45/46-1 GRASPING FORCEPS | December 15, 1995 |
| K954377 | annex medical | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | October 26, 1995 |
| K951532 | annex medical | METAL URETERAL BASKET STONE DISLODGER | July 19, 1995 |
| K951761 | annex medical | METEL URETERAL BASKET STONE DISLODGER | May 11, 1995 |
| K935737 | boston scientific | STONE EXTRACTOR, GRASPING FORCEPS | September 7, 1994 |
| K935721 | boston scientific | STONE EXTRACTOR | August 22, 1994 |
| K934636 | annex medical | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | February 25, 1994 |
| K933260 | surgitek | HELICAL STONE/FLATWIRE STONE BASKETS | January 11, 1994 |
| K934675 | annex medical | METAL URETERAL BASKET STONE DISLODGER | January 7, 1994 |
| K930349 | endomedix | STONE RETRIEVAL BASKET | June 9, 1993 |