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510(k) K943078

HOT BIOPSY FORCEPS by Intl. Medical, Inc. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1994
Date Received
June 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Intl. Medical, Inc.

  • K970507 — PEAK FLOW METER (June 13, 1997)
  • 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)
  • K912605 — AMCATH DISPOSABLE MICRO SCISSORS (July 11, 1991)

Other clearances for product code KGE

  • K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (March 6, 2026)
  • K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
  • K242857 — ClearHemograsper (May 21, 2025)
  • K231721 — Disposable Hot Biopsy Forceps (December 14, 2023)
  • K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (February 4, 2022)
  • K210406 — Bipolar Coagulation Foreceps (October 5, 2021)
  • K202438 — Ensure Single-Use Coagulation Forceps (March 15, 2021)
  • K183428 — Avulsion Forceps (April 16, 2019)
  • K180018 — Disposable Hot Biopsy Forceps (July 5, 2018)
  • K180134 — Ensizor Monopolar Endoscopic Scissors (June 29, 2018)