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510(k) K902555

AMCATH COAGULATION PROBE by Intl. Medical, Inc. — Product Code HFG

K902555 is an FDA 510(k) premarket notification submitted by Intl. Medical, Inc. for the device "AMCATH COAGULATION PROBE". The FDA issued a decision of Substantially Equivalent on June 20, 1990. The device falls under product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Intl. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1990
Date Received
June 8, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
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)
  • K915142 — AMCATH DISPOSABLE BIOPSY FORCEPS (January 10, 1992)
  • K912927 — AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE (September 19, 1991)

Other clearances for product code HFG

  • K181124 — Acessa ProVu System (September 28, 2018)
  • K132744 — ACESSA GUIDANCE SYSTEM (May 27, 2014)
  • K132184 — ACESSA GUIDANCE HANDPIECE (April 28, 2014)
  • K121858 — THE ABLATION SYSTEM (November 5, 2012)
  • K101606 — MICROMED PD-8K INSULATION DEFECT DETECTOR (October 1, 2010)
  • K991424 — INSULSCAN INSULATION TESTING SYSTEM (July 22, 1999)
  • K961695 — ENDO-TECH LTD., TIPS (July 1, 1996)
  • K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (March 25, 1994)
  • K915406 — DAVOL ELECTROSUGICAL PROBES (February 28, 1992)
  • K904240 — SINGLE USE LAPARSCOPIC ELECTRODE (February 19, 1991)

FDA data resources