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510(k) K001496

A.V. FISTULA NEEDLE by Exelint International, Co. — Product Code FIE

K001496 is an FDA 510(k) premarket notification submitted by Exelint International, Co. for the device "A.V. FISTULA NEEDLE". The FDA issued a decision of Substantially Equivalent on Aug 1, 2000. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Exelint International, Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 1, 2000
Date Received
May 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Exelint International, Co.

  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (Dec 12, 2025)
  • K152183 — EXELINT SecureTouch Safety Hypodermic Needle (Nov 2, 2015)
  • K101309 — EXELINT ALUMINUM HUB BLUNT NEEDLES (Oct 20, 2010)
  • K020189 — EXEL BUTTERFLY SCALP VEIN SET (Mar 27, 2003)
  • K010197 — EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET (May 14, 2001)
  • K003627 — EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET (Feb 8, 2001)

Other clearances for product code FIE

  • K253469 — Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritu (Aug 6, 2026)
  • K251877 — JMS CAVEO A.V. Fistula Needle Set (Aug 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (Apr 8, 2022)
  • K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposa (May 17, 2018)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (Jul 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (Jan 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (Dec 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (Sep 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (Apr 24, 2012)

FDA data resources