FFL · Class II · 21 CFR 876.4680

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

Leading manufacturers include Van-Tec, Inc., Annex Medical, Inc. and C.R. Bard, Inc..

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 Sep 19, 2017
Accordion Piccolo Stone Management Device
K172299
Ths International, Inc. D/B/A Accordion Medical
Gastroenterology & Urology · 50d
Cleared Sep 13, 2005
ACCORDION
K052048
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 46d
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 Mar 19, 1997
COMEG ENDOSCOPY GRASPING FORCEPS
K970489
Comeg Endoscopy
Gastroenterology & Urology · 37d
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 Oct 26, 1995
FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC
K954377
Annex Medical, Inc.
Gastroenterology & Urology · 37d
Cleared Jul 19, 1995
METAL URETERAL BASKET STONE DISLODGER
K951532
Annex Medical, Inc.
Gastroenterology & Urology · 107d
Cleared May 11, 1995
METEL URETERAL BASKET STONE DISLODGER
K951761
Annex Medical, Inc.
Gastroenterology & Urology · 24d
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 Feb 25, 1994
ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR
K934636
Annex Medical, Inc.
Gastroenterology & Urology · 151d
Cleared Jan 11, 1994
HELICAL STONE/FLATWIRE STONE BASKETS
K933260
Surgitek
Gastroenterology & Urology · 189d
Cleared Jan 07, 1994
METAL URETERAL BASKET STONE DISLODGER
K934675
Annex Medical, Inc.
Gastroenterology & Urology · 101d
Cleared Oct 20, 1992
DISLODGER, STONE, BASKET, URETERAL, METAL
K924027
Annex Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 25, 1992
LOOP RETRIEVER
K922678
Annex Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 27, 1992
BARD 4-WIRE URETEROSCOPIC STONE
K921233
C.R. Bard, Inc.
Gastroenterology & Urology · 45d
Cleared Mar 11, 1991
LOOP RETRIEVER
K910603
Annex Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Jul 03, 1990
PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE
K900269
Porges Corp.
Gastroenterology & Urology · 166d
Cleared Feb 08, 1990
METAL URETERAL BASKET STONE DISLODGER
K896992
Annex Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Dec 18, 1989
METAL URETERAL BASKET STONE DISLODGER
K896169
Annex Medical, Inc.
Gastroenterology & Urology · 54d

About Product Code FFL - Regulatory Context