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510(k) K131991

ENDOCHOICE HOT BIOPSY FORCEPS by Endochoice, Inc. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2013
Date Received
June 28, 2013
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 Endochoice, Inc.

  • K160275 — Fuse Endoscopic System with FuseBox Processor (August 1, 2016)
  • K161482 — EndoChoice Water Bottle Cap Irrigation System (June 27, 2016)
  • K161167 — Seal Single-Use Biopsy Valve (May 26, 2016)
  • K160403 — SmartStart Air/Water and Suction Valves (May 19, 2016)
  • K153588 — EndoChoice Water Bottle Cap System (February 24, 2016)
  • K151475 — EndoChoice Select Injection Needle (February 8, 2016)
  • K152182 — Fuse Gastroscopy System (December 10, 2015)
  • K152580 — rescuenet (November 3, 2015)
  • K142155 — ENDOCHOICE WATER BOTTLE CAP SYSTEM (January 20, 2015)
  • K140472 — BONASTENT TRACHEAL / BRONCHIAL (October 17, 2014)

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)