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510(k) K151474

Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) by Fujifilm Medical System U.S.A., Inc. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2016
Date Received
June 1, 2015
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 Fujifilm Medical System U.S.A., Inc.

  • K163675 — Processor VP-7000, Light Source BL-7000 (April 25, 2017)
  • K153206 — Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (March 3, 2016)
  • K152138 — FDR D-EVO GL Flat Panel Detector System (November 5, 2015)
  • K150221 — EPX-4440HD and EPX-4400HD with FICE (October 1, 2015)
  • K142629 — EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes (May 14, 2015)
  • K142003 — FDR D-EVO II FLAT PANEL DETECTOR SYSTEM (October 21, 2014)
  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132188 — MAMMOGRAPHY VIEWER SMV658 (October 25, 2013)
  • K130542 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (June 14, 2013)
  • K130383 — SYNAPSE 3D CARDIAC TOOLS (April 9, 2013)

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)