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510(k) K952863

FORCEPS, BIOPSY, NON-ELECTRIC by Annex Medical, Inc. — Product Code FCL

K952863 is an FDA 510(k) premarket notification submitted by Annex Medical, Inc. for the device "FORCEPS, BIOPSY, NON-ELECTRIC". The FDA issued a decision of Substantially Equivalent on July 19, 1995. The device falls under product code FCL (Forceps, Biopsy, Non-Electric), a Class I device regulated under 21 CFR 876.1075. Annex Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1995
Date Received
June 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Non-Electric
Device Class
Class I
Regulation Number
876.1075
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)
  • 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)
  • 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 FCL

  • K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (July 16, 2003)
  • K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS (December 2, 1997)
  • K971315 — AUXILIARY INSTRUMENTS FOR URS (September 15, 1997)
  • K964120 — INJECTO FLUSH (December 30, 1996)
  • K963517 — SPECTRA SCIENCE BIOPSY FORCEPS (December 2, 1996)
  • K955065 — OLYMPUS FB SERIES BIOPSY FORCEPS (January 24, 1996)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K950559 — DIENER RETRIEVAL DEVICES (February 16, 1995)

FDA data resources