Atlas FDA

STONE EXTRACTOR, GRASPING FORCEPS

FDA 510(k) clearance K935737 · decided 1994-09-07

Clearance details

K-number
K935737
Device name
STONE EXTRACTOR, GRASPING FORCEPS
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
1993-12-01
Decision date
1994-09-07
Days to decision
280 days
Clearance type
Traditional
Product code
FFL
Device class
2
Regulation number
876.4680
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Watertown, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Peralta Stone Removal Catheter (K190492)Calcula Technologies, Inc.2019-07-18
Accordion Piccolo Stone Management Device (K172299)Ths International, Inc. D/B/A Accordion Medical2017-09-19
ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (K102887)Percutaneous Systems, Inc.2011-05-16
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (K082803)Percutaneous Systems, Inc.2008-11-13
ACCORDION (K052048)Percutaneous Systems, Incorporated2005-09-13
REPROCESSED STONE RETRIEVAL BASKETS (K012581)Sterilmed, Inc.2002-02-14
AMS FOREIGN BODY EXTRATOR (K972091)American Medical Systems, Inc.1997-08-29
COMEG ENDOSCOPY GRASPING FORCEPS (K970489)Comeg Endoscopy1997-03-19
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (K962387)Olympus America, Inc.1996-07-31
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS (K961248)C.R. Bard, Inc.1996-05-28
OLYMPUS FG-45/46-1 GRASPING FORCEPS (K955049)Olympus America, Inc.1995-12-15
FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC (K954377)Annex Medical, Inc.1995-10-26

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (N970003/S304)Boston Scientific Corp2025-12-19
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374)Boston Scientific Corp2025-12-18
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082)Boston Scientific Corp2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (N970003/S305)Boston Scientific Corp2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079)Boston Scientific Corp2025-12-15
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078)Boston Scientific Corp2025-12-15