Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4680](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4680) → FFL — Dislodger, Stone, Basket, Ureteral, Metal # FFL · Dislodger, Stone, Basket, Ureteral, Metal _Gastroenterology, Urology · 21 CFR 876.4680 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL ## Overview - **Product Code:** FFL - **Device Name:** Dislodger, Stone, Basket, Ureteral, Metal - **Regulation:** [21 CFR 876.4680](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4680) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## 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](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K190492.md) | Peralta Stone Removal Catheter | Calcula Technologies, Inc. | Jul 18, 2019 | SESE | | [K172299](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K172299.md) | Accordion Piccolo Stone Management Device | Ths International, Inc. D/B/A Accordion Medical | Sep 19, 2017 | SESE | | [K102887](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K102887.md) | ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 | Percutaneous Systems, Inc. | May 16, 2011 | SESE | | [K082803](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K082803.md) | COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 | Percutaneous Systems, Inc. | Nov 13, 2008 | SESE | | [K052048](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K052048.md) | ACCORDION | Percutaneous Systems, Incorporated | Sep 13, 2005 | SESE | | [K012581](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K012581.md) | REPROCESSED STONE RETRIEVAL BASKETS | Sterilmed, Inc. | Feb 14, 2002 | SESE | | [K972091](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K972091.md) | AMS FOREIGN BODY EXTRATOR | American Medical Systems, Inc. | Aug 29, 1997 | SESE | | [K970489](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K970489.md) | COMEG ENDOSCOPY GRASPING FORCEPS | Comeg Endoscopy | Mar 19, 1997 | SESE | | [K962387](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K962387.md) | OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) | Olympus America, Inc. | Jul 31, 1996 | SESE | | [K961248](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K961248.md) | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS | C.R. Bard, Inc. | May 28, 1996 | SESE | | [K955049](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K955049.md) | OLYMPUS FG-45/46-1 GRASPING FORCEPS | Olympus America, Inc. | Dec 15, 1995 | SESE | | [K954377](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K954377.md) | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | Annex Medical, Inc. | Oct 26, 1995 | SESE | | [K951532](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K951532.md) | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | Jul 19, 1995 | SESE | | [K951761](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K951761.md) | METEL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | May 11, 1995 | SESE | | [K935737](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K935737.md) | STONE EXTRACTOR, GRASPING FORCEPS | Boston Scientific Corp | Sep 7, 1994 | SESE | | [K935721](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K935721.md) | STONE EXTRACTOR | Boston Scientific Corp | Aug 22, 1994 | SESE | | [K934636](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K934636.md) | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | Annex Medical, Inc. | Feb 25, 1994 | SESE | | [K933260](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K933260.md) | HELICAL STONE/FLATWIRE STONE BASKETS | Surgitek | Jan 11, 1994 | SESE | | [K934675](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K934675.md) | METAL URETERAL BASKET STONE DISLODGER | Annex Medical, Inc. | Jan 7, 1994 | SESE | | [K930349](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL/K930349.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com