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510(k) K934598

GRASPING FORCEPS OR RETRIEVAL FORCEPS by Annex Medical, Inc. — Product Code FGO

K934598 is an FDA 510(k) premarket notification submitted by Annex Medical, Inc. for the device "GRASPING FORCEPS OR RETRIEVAL FORCEPS". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code FGO (Dislodger, Stone, Flexible), 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
January 7, 1994
Date Received
September 24, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
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)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K951532 — METAL URETERAL BASKET STONE DISLODGER (July 19, 1995)
  • K951761 — METEL URETERAL BASKET STONE DISLODGER (May 11, 1995)
  • K934636 — ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR (February 25, 1994)
  • K934675 — METAL URETERAL BASKET STONE DISLODGER (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 FGO

  • K001563 — SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (November 22, 2000)
  • K970121 — STONE DISLODGER, BASKET (April 2, 1997)
  • K963750 — RETRIEVAL SNARE (November 22, 1996)
  • K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (October 4, 1996)
  • K951309 — STONE DISLODGER, BASKET (May 17, 1995)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914110 — GRASPING FORCEPS (February 28, 1992)
  • K914111 — METAL URETERAL BASKET STONE DISLODGER, HELICAL (February 28, 1992)

FDA data resources