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510(k) K915142

AMCATH DISPOSABLE BIOPSY FORCEPS by Intl. Medical, Inc. — Product Code FCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1992
Date Received
November 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Mechanical, Gastrointestinal
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Intl. Medical, Inc.

  • K970507 — PEAK FLOW METER (June 13, 1997)
  • K943078 — HOT BIOPSY FORCEPS (November 14, 1994)
  • K940370 — AMERICAN CATHETER E.R.C.P. CANNULA (August 17, 1994)
  • K940335 — AMERICAN CATHETER POLY-SNARE (July 21, 1994)
  • K942068 — AMERICAN CATHETER SPHINCTEROTOME (June 24, 1994)
  • K930410 — DURHAM; LUER LOCK EXTENSION SET (September 3, 1993)
  • K930406 — DURHAM; MIN BORE LUER LOCK EXTENSION SET (September 3, 1993)
  • K923200 — AMCATH DISPOSABLE CYTOLOGY BRUSH (December 7, 1992)
  • K912927 — AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE (September 19, 1991)
  • K912605 — AMCATH DISPOSABLE MICRO SCISSORS (July 11, 1991)

Other clearances for product code FCF

  • K070759 — POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM (May 21, 2007)
  • K062833 — POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM (November 30, 2006)
  • K984168 — BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE (December 7, 1999)
  • K911155 — OVAL CUP BIOPSY FORCEP (August 7, 1991)
  • K843477 — PHARMA-PLAST RECTAL TIP (December 5, 1984)