Product Code: FFL FDA class 2 21 CFR 876.4680

Dislodger, Stone, Basket, Ureteral, Metal

Gastroenterology, Urology

The Metal Ureteral Stone Basket Dislodger is a rigid or semi-rigid wire basket device inserted through a ureteroscope or cystoscope to capture, dislodge, and retrieve stones from the ureter. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FFL, regulated under 21 CFR 876.4680, within the Gastroenterology, Urology medical specialty.

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510(k)s

FEI Numbers

101

Registration Numbers

101

Unique Applicants

Years Active

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Basic Information

Product Code: FFL
Device Class: FDA class 2
Regulation Number: 876.4680
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 52 510(k) clearances via K numbers.

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