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510(k) K010448

HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES by Horizons Intl. Corp. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2001
Date Received
February 15, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

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)
  • K011667 — HORIZONS INTERNATIONAL POLYPECTOMY SNARES (August 16, 2001)
  • K002235 — HORIZONS ERCP CANNULA (January 23, 2001)
  • K002236 — HORIZONS PAPILLOTOME (January 23, 2001)

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  • K232442 — Disposable Endoscope Injection Needles (November 9, 2023)
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  • K222006 — Sclerotherapy & Endoscopic Needles (April 3, 2023)