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510(k) K010448

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

K010448 is an FDA 510(k) premarket notification submitted by Horizons Intl. Corp. for the device "HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES". The FDA issued a decision of Substantially Equivalent on May 16, 2001. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Horizons Intl. Corp. has at least 9 other 510(k) clearances on record.

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)
  • 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)
  • 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)

Other clearances for product code FBK

  • K260262 — Injection Needle (May 29, 2026)
  • K253598 — InjecSURE Injection System (March 31, 2026)
  • K252021 — Disposable Endoscopic Injection Needles (December 2, 2025)
  • K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
  • K241595 — EzVu Visual Vasopressor injector (EV-19) (February 27, 2025)
  • K240675 — Endoscopic Injection Needles (October 4, 2024)
  • K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) (August 27, 2024)
  • K232200 — Disposable Injection Needles (April 12, 2024)
  • K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810) (March 8, 2024)
  • K232442 — Disposable Endoscope Injection Needles (November 9, 2023)

FDA data resources