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510(k) K840818

BIOPSY FORCEPS by American Endoscopy, Inc. — Product Code FCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1984
Date Received
February 24, 1984
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 American Endoscopy, Inc.

  • K853274 — AMERICAN DILATATION SYSTEM (October 17, 1985)
  • K841384 — PROXIMA 1 PH MONITOR (July 19, 1984)
  • K833491 — ENDO BITE BLOCK (April 25, 1984)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K833492 — PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (November 29, 1983)
  • K832458 — AUTOMATIC ENDOSCOPE (October 20, 1983)
  • K821818 — RETRIEVAL BALLOONS (September 24, 1982)
  • K821819 — PIGTAIL STENTS (August 20, 1982)
  • K822062 — BALL TIP COAGULATING ELECTRODES (August 19, 1982)
  • K821817 — PIGTAIL NASAL CATHETERS (August 10, 1982)

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)
  • K952863 — FORCEPS, BIOPSY, NON-ELECTRIC (July 19, 1995)
  • K952391 — DYNABITE UROLOGICAL FORCEPS (June 1, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)