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510(k) K011667

HORIZONS INTERNATIONAL POLYPECTOMY SNARES by Horizons Intl. Corp. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2001
Date Received
May 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
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)
  • K022243 — HORIZONS REUSABLE HOT BIOPSY FORCEPS (October 25, 2002)
  • 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)
  • K010448 — HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES (May 16, 2001)
  • K002236 — HORIZONS PAPILLOTOME (January 23, 2001)
  • K002235 — HORIZONS ERCP CANNULA (January 23, 2001)

Other clearances for product code FDI

  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K221713 — Polypectomy Snare (March 3, 2023)
  • K220846 — CORE-SNARE (November 21, 2022)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (June 27, 2022)
  • K213222 — Disposable Polypectomy Snare (June 6, 2022)
  • K212860 — SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB- (October 7, 2021)
  • K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snare (October 8, 2020)
  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (November 22, 2019)