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510(k) K021706

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

K021706 is an FDA 510(k) premarket notification submitted by Horizons Intl. Corp. for the device "HORIZONS HOT BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on June 21, 2002. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Horizons Intl. Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2002
Date Received
May 23, 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)
  • K022243 — HORIZONS REUSABLE HOT BIOPSY FORCEPS (October 25, 2002)
  • K022546 — HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES (August 12, 2002)
  • K021998 — HORIZONS CYTOLOGY BRUSH (July 12, 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)

FDA data resources