FFL · Class II · 21 CFR 876.4680

FDA Product Code FFL: Dislodger, Stone, Basket, Ureteral, Metal

Leading manufacturers include Van-Tec, Inc., C.R. Bard, Inc. and Boston Scientific Corp.

52
Total
52
Cleared
80d
Avg days
1979
Since

FDA 510(k) Cleared Dislodger, Stone, Basket, Ureteral, Metal Devices (Product Code FFL)

52 devices
1–24 of 52
Cleared Jul 18, 2019
Peralta Stone Removal Catheter
K190492
Calcula Technologies, Inc.
Gastroenterology & Urology · 140d
Cleared Feb 14, 2002
REPROCESSED STONE RETRIEVAL BASKETS
K012581
Sterilmed, Inc.
Gastroenterology & Urology · 189d
Cleared Aug 29, 1997
AMS FOREIGN BODY EXTRATOR
K972091
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 31, 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
K962387
Olympus America, Inc.
Gastroenterology & Urology · 41d
Cleared May 28, 1996
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
K961248
C.R. Bard, Inc.
Gastroenterology & Urology · 57d
Cleared Dec 15, 1995
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K955049
Olympus America, Inc.
Gastroenterology & Urology · 39d
Cleared Sep 07, 1994
STONE EXTRACTOR, GRASPING FORCEPS
K935737
Boston Scientific Corp
Gastroenterology & Urology · 280d
Cleared Aug 22, 1994
STONE EXTRACTOR
K935721
Boston Scientific Corp
Gastroenterology & Urology · 265d
Cleared Apr 27, 1992
BARD 4-WIRE URETEROSCOPIC STONE
K921233
C.R. Bard, Inc.
Gastroenterology & Urology · 45d
Cleared Feb 09, 1989
CANDELA STONE BASKETS
K884738
Candela Laser Corp.
Gastroenterology & Urology · 87d
Cleared Jun 17, 1987
VAN-TEC REUSABLE HELICAL STONE BASKET
K871777
Van-Tec, Inc.
Gastroenterology & Urology · 42d
Cleared Jun 17, 1987
HELICAL STONE BASKET (DISPOSABLE)
K871779
Van-Tec, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 30, 1987
VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH
K870696
Van-Tec, Inc.
Gastroenterology & Urology · 39d
Cleared Mar 25, 1987
VAN-TEC POSITIVE OPEN SEGURA BASKET
K870615
Van-Tec, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 10, 1987
SEGURA DRETLER BASKET
K864874
Van-Tec, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 24, 1986
4-WIRE (CARSON) STONE EXTRACTOR
K863081
Cook Urological, Inc.
Gastroenterology & Urology · 73d
Cleared May 15, 1986
DUTHOY STONE BASKET
K861469
Lake Region Mfg., Inc.
Gastroenterology & Urology · 23d
Cleared Apr 03, 1986
VAN-TEC DEFLECTING GRASPING FORCEPS
K860268
Van-Tec, Inc.
Gastroenterology & Urology · 66d
Cleared Apr 03, 1986
DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER
K860946
Van-Tec, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 25, 1986
VAN-TEC DEFLECTING LOOP RETRIEVER
K860269
Van-Tec, Inc.
Gastroenterology & Urology · 57d
Cleared Mar 25, 1986
VAN-TEC DEFLECTING ROTATING SEGURA BASKET
K860270
Van-Tec, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 29, 1985
WILSON-COOK STONE EXTRACTOR
K851965
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 03, 1985
URETERAL DILATOR & URETERAL STONE DISLODGER
K850954
American Edwards Laboratories
Gastroenterology & Urology · 26d
Cleared Jul 19, 1984
SEGURA BASKET
K841942
Van-Tec, Inc.
Gastroenterology & Urology · 69d

About Product Code FFL - Regulatory Context