FDA 510(k) Applications for Medical Device Product Code "FFL"
(Dislodger, Stone, Basket, Ureteral, Metal)

FDA 510(k) Number Applicant Device Name Decision Date
K972091 AMERICAN MEDICAL SYSTEMS, INC. AMS FOREIGN BODY EXTRATOR 08/29/1997
K961248 C.R. BARD, INC. BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS 05/28/1996
K190492 Calcula Technologies, Inc Peralta Stone Removal Catheter 07/18/2019
K970489 COMEG ENDOSCOPY COMEG ENDOSCOPY GRASPING FORCEPS 03/19/1997
K962387 OLYMPUS AMERICA, INC. OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) 07/31/1996
K102887 PERCUTANEOUS SYSTEMS, INC. ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 05/16/2011
K082803 PERCUTANEOUS SYSTEMS, INC. COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 11/13/2008
K052048 PERCUTANEOUS SYSTEMS, INCORPORATED ACCORDION 09/13/2005
K012581 STERILMED, INC. REPROCESSED STONE RETRIEVAL BASKETS 02/14/2002
K172299 THS International, Inc. d/b/a Accordion Medical Accordion Piccolo Stone Management Device 09/19/2017


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