Home / 510(k) Clearances / K960519

510(k) K960519

MARTECH ENDOSCOPIC INJECTION NEEDLE by Martech Medical Products, Inc. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1996
Date Received
February 5, 1996
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 Martech Medical Products, Inc.

  • K130855 — PTFE SUPER SHEATH INTRODUCER (July 29, 2013)
  • K120617 — PTFE SUPER SHEATH INTRODUCER (November 19, 2012)
  • K101399 — COAXIAL INTRODUCER SET (June 17, 2010)
  • K931924 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (August 3, 1993)
  • K922438 — PRO2 OXYGEN ANALYZER (March 5, 1993)
  • K926007 — ACCESSORY TO PISTON SYRINGE (February 23, 1993)
  • K914778 — NEOLINE(TM) (September 16, 1992)
  • K910970 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (October 15, 1991)
  • K890473 — NEEDLE GUARD(TM) (April 3, 1989)

Other clearances for product code FBK

  • 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)
  • K230925 — Disposable Injection Needle AF series (September 27, 2023)
  • K222006 — Sclerotherapy & Endoscopic Needles (April 3, 2023)