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510(k) K934636

ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR by Annex Medical, Inc. — Product Code FFL

K934636 is an FDA 510(k) premarket notification submitted by Annex Medical, Inc. for the device "ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code FFL (Dislodger, Stone, Basket, Ureteral, Metal), a Class II device regulated under 21 CFR 876.4680. Annex Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1994
Date Received
September 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Basket, Ureteral, Metal
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances by Annex Medical, Inc.

  • K954377 — FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC (October 26, 1995)
  • K951532 — METAL URETERAL BASKET STONE DISLODGER (July 19, 1995)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K951761 — METEL URETERAL BASKET STONE DISLODGER (May 11, 1995)
  • K934675 — METAL URETERAL BASKET STONE DISLODGER (January 7, 1994)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K925267 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (February 10, 1993)
  • K925559 — BILIARY STONE DISLODGER (December 17, 1992)
  • K921401 — BIOPSY FORCEPS (October 21, 1992)
  • K924027 — DISLODGER, STONE, BASKET, URETERAL, METAL (October 20, 1992)

Other clearances for product code FFL

  • K190492 — Peralta Stone Removal Catheter (July 18, 2019)
  • K172299 — Accordion Piccolo Stone Management Device (September 19, 2017)
  • K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510 (May 16, 2011)
  • K082803 — COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015 (November 13, 2008)
  • K052048 — ACCORDION (September 13, 2005)
  • K012581 — REPROCESSED STONE RETRIEVAL BASKETS (February 14, 2002)
  • K972091 — AMS FOREIGN BODY EXTRATOR (August 29, 1997)
  • K970489 — COMEG ENDOSCOPY GRASPING FORCEPS (March 19, 1997)
  • K962387 — OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) (July 31, 1996)
  • K961248 — BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BA (May 28, 1996)

FDA data resources