FDA.reportPublic FDA data

510(k) K921233

Device
Bard 4-wire Ureteroscopic Stone
Applicant
C.R. BARD, INC.
510(k) number
K921233
Product code
FFL
Decision
Substantially Equivalent (SESE)
Decision date
1992-04-27
Date received
1992-03-13
Regulation
876.4680
Classification name
Dislodger, Stone, Basket, Ureteral, Metal
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DONNA J WILSON
Address
8195 Industrial Blvd. Covington GA US 30014 30014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K190492Peralta Stone Removal CatheterCalcula Technologies, Inc.2019-07-18
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K102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510Percutaneous Systems, Inc.2011-05-16
K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015Percutaneous Systems, Inc.2008-11-13
K052048ACCORDIONPercutaneous Systems, Incorporated2005-09-13
K012581REPROCESSED STONE RETRIEVAL BASKETSSterilmed, Inc.2002-02-14
K972091AMS FOREIGN BODY EXTRATORAmerican Medical Systems, Inc.1997-08-29
K970489COMEG ENDOSCOPY GRASPING FORCEPSComeg Endoscopy1997-03-19
K962387OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)Olympus America, Inc.1996-07-31
K961248BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPSC.R. Bard, Inc.1996-05-28
K955049OLYMPUS FG-45/46-1 GRASPING FORCEPSOlympus America, Inc.1995-12-15
K954377FORCEPS, GRASPING, FLEXIBLE ENDOSCOPICAnnex Medical, Inc.1995-10-26
K951532METAL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.1995-07-19
K951761METEL URETERAL BASKET STONE DISLODGERAnnex Medical, Inc.1995-05-11
K935737STONE EXTRACTOR, GRASPING FORCEPSBoston Scientific Corp1994-09-07