510(k) K915142

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

K915142 is an FDA 510(k) premarket notification submitted by Intl. Medical, Inc. for the device "AMCATH DISPOSABLE BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on January 10, 1992. The device falls under product code FCF (Instrument, Biopsy, Mechanical, Gastrointestinal), a Class II device regulated under 21 CFR 876.1075. Intl. Medical, Inc. has at least 10 other 510(k) clearances on record.

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)

510(k) K915142

Clearance Details

Device Classification

Other clearances by Intl. Medical, Inc.

Other clearances for product code FCF

FDA data resources