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510(k) K022243

HORIZONS REUSABLE HOT BIOPSY FORCEPS by Horizons Intl. Corp. — Product Code KGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
July 12, 2002
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 Horizons Intl. Corp.

  • K083049 — TORNADO ROTATABEL SNARE AND POLYP CATCHER (December 23, 2008)
  • K022268 — HORIZONS REUSABLE POLYPECTOMY SNARES (October 25, 2002)
  • K022546 — HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES (August 12, 2002)
  • K021998 — HORIZONS CYTOLOGY BRUSH (July 12, 2002)
  • K021706 — HORIZONS HOT BIOPSY FORCEPS (June 21, 2002)
  • K011667 — HORIZONS INTERNATIONAL POLYPECTOMY SNARES (August 16, 2001)
  • K010448 — HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES (May 16, 2001)
  • K002235 — HORIZONS ERCP CANNULA (January 23, 2001)
  • K002236 — HORIZONS PAPILLOTOME (January 23, 2001)

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)