Home / 510(k) Clearances / K902564

510(k) K902564

NEEDLE, DIALYSIS by Gainor Medical Europe, Ltd. — Product Code FIE

K902564 is an FDA 510(k) premarket notification submitted by Gainor Medical Europe, Ltd. for the device "NEEDLE, DIALYSIS". The FDA issued a decision of Substantially Equivalent on March 1, 1991. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Gainor Medical Europe, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1991
Date Received
June 11, 1990
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 Gainor Medical Europe, Ltd.

  • K926448 — I.V. ADMINISTRATION SET (May 2, 1994)
  • K931828 — CARELET SAFETY LANCET (October 15, 1993)
  • K931827 — CLEANLET, CLEANLET XL & KIDS (September 13, 1993)
  • K922441 — SURESEAL BANDAGE (August 10, 1993)
  • K913333 — I.V. PRIMING SET (October 23, 1991)
  • K902422 — NEEDLE, ASPIRATION & INJECTION, DISPOSABLE (June 6, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K902421 — STOMACH, GASTRO-ENTEROSTOMY (November 20, 1990)
  • K902426 — HEMODIALYSIS SYSTEM AND ACCESSORY (November 20, 1990)
  • K902416 — SURELITE AND SURELITE XL BLOOD LANCET (August 1, 1990)

Other clearances for product code FIE

  • K251877 — JMS CAVEO A.V. Fistula Needle Set (August 15, 2025)
  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 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 (July 20, 2017)
  • K151017 — JMS Harmony A.V. Fistula Needle Set (May 13, 2015)
  • K131950 — ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET (January 16, 2015)
  • K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle S (December 23, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)
  • K112734 — APLAN A.V. FISTULA NEEDLE SET (April 24, 2012)
  • K112178 — JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (October 27, 2011)

FDA data resources