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510(k) K904985

BIPOLAR BIOPSY FORCEPS by Everest Medical Corp. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1991
Date Received
November 2, 1990
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 Everest Medical Corp.

  • K003060 — PLASMAKINETIC GENERATOR (October 31, 2000)
  • K000496 — EVERSHEARS BIPOLAR SCISSORS (April 24, 2000)
  • K993412 — BITX PROBES (March 31, 2000)
  • K994336 — BITX PROBES (February 8, 2000)
  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K955001 — EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS (December 13, 1995)
  • K945975 — EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS (December 21, 1994)
  • K922509 — LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA (October 1, 1992)
  • K922246 — TUBING SET W/ IRRIGATION & ASPIRATION VALVING (September 2, 1992)
  • K920089 — MONOPOLAR COAGULATING POLYPECTOMY SNARE (March 31, 1992)

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)