FFL · Dislodger, Stone, Basket, Ureteral, Metal
Gastroenterology, Urology · 21 CFR 876.4680 · Class 2
Overview
| Product Code | FFL |
|---|---|
| Device Name | Dislodger, Stone, Basket, Ureteral, Metal |
| Regulation | 21 CFR 876.4680 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Recent Cleared Devices (20 of 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190492 | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | Jul 18, 2019 | SESE |
| K172299 | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | Sep 19, 2017 | SESE |
| K102887 | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | Percutaneous Systems, Inc. | May 16, 2011 | SESE |
| K082803 | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 | Percutaneous Systems, Inc. | Nov 13, 2008 | SESE |
| K052048 | ACCORDION | Percutaneous Systems, Incorporated | Sep 13, 2005 | SESE |
| K012581 | REPROCESSED STONE RETRIEVAL BASKETS | Sterilmed, Inc. | Feb 14, 2002 | SESE |
| K972091 | AMS FOREIGN BODY EXTRATOR | American Medical Systems, Inc. | Aug 29, 1997 | SESE |
| K970489 | COMEG ENDOSCOPY GRASPING FORCEPS | Comeg Endoscopy | Mar 19, 1997 | SESE |
| K962387 | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) | Olympus America, Inc. | Jul 31, 1996 | SESE |
| K961248 | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS | C.R. Bard, Inc. | May 28, 1996 | SESE |
| K955049 | OLYMPUS FG-45/46-1 GRASPING FORCEPS | Olympus America, Inc. | Dec 15, 1995 | SESE |
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | Annex Medical, Inc. | Oct 26, 1995 | SESE |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | Jul 19, 1995 | SESE |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | May 11, 1995 | SESE |
| K935737 | STONE EXTRACTOR, GRASPING FORCEPS | Boston Scientific Corp | Sep 7, 1994 | SESE |
| K935721 | STONE EXTRACTOR | Boston Scientific Corp | Aug 22, 1994 | SESE |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | Annex Medical, Inc. | Feb 25, 1994 | SESE |
| K933260 | HELICAL STONE/FLATWIRE STONE BASKETS | Surgitek | Jan 11, 1994 | SESE |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | Jan 7, 1994 | SESE |
| K930349 | STONE RETRIEVAL BASKET | Endomedix | Jun 9, 1993 | SESE |
Top Applicants
- Annex Medical, Inc. — 10 clearances
- Van-Tec, Inc. — 10 clearances
- Boston Scientific Corp — 2 clearances
- C.R. Bard, Inc. — 2 clearances
- Olympus America, Inc. — 2 clearances
