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510(k) K921401

BIOPSY FORCEPS by Annex Medical, Inc. — Product Code DWZ

K921401 is an FDA 510(k) premarket notification submitted by Annex Medical, Inc. for the device "BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on October 21, 1992. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Annex Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1992
Date Received
March 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biopsy, Endomyocardial
Device Class
Class II
Regulation Number
870.4075
Review Panel
CV
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)
  • 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)
  • K924027 — DISLODGER, STONE, BASKET, URETERAL, METAL (October 20, 1992)

Other clearances for product code DWZ

  • K252722 — Biopsy Forceps (September 30, 2025)
  • K170726 — Biopsy Forceps (June 2, 2017)
  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K010473 — SPARROWHAWK DISPOSABLE (June 6, 2001)
  • K000409 — MODIFICATION TO T-REX BIOPSY FORCEPS (February 28, 2000)
  • K991486 — ULTRA-CBX (November 5, 1999)
  • K973818 — T-REX BIOPSY FORCEPS (December 16, 1997)
  • K974175 — HEARTPORT ENDOAORTIC CLAMP CATHETER (December 16, 1997)
  • K951447 — DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (July 27, 1995)
  • K933235 — CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF (January 6, 1994)

FDA data resources