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510(k) K090796

MULTI-BITE HOT BIOPSY FORCEPS by Endo-Therapeutics, Inc. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2009
Date Received
March 24, 2009
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 Endo-Therapeutics, Inc.

  • K031026 — ETI BIPOLAR HEMOSTATIC PROBE (June 27, 2003)
  • K023603 — ENDO-GLIDE GUIDEWIRE (February 19, 2003)
  • K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGER (November 8, 2001)
  • K012977 — VARICES INJECTION NEEDLE (November 2, 2001)
  • K926549 — ENDOCATH ELECTROPHYSIOLOGY CATHETER (December 6, 1993)
  • K925392 — BIOPSY FORCEPS (November 5, 1993)

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)