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510(k) K902422

NEEDLE, ASPIRATION & INJECTION, DISPOSABLE by Gainor Medical Europe, Ltd. — Product Code FMI

K902422 is an FDA 510(k) premarket notification submitted by Gainor Medical Europe, Ltd. for the device "NEEDLE, ASPIRATION & INJECTION, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on June 6, 1991. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Gainor Medical Europe, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
May 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
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)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K902564 — NEEDLE, DIALYSIS (March 1, 1991)
  • K902426 — HEMODIALYSIS SYSTEM AND ACCESSORY (November 20, 1990)
  • K902421 — STOMACH, GASTRO-ENTEROSTOMY (November 20, 1990)
  • K902416 — SURELITE AND SURELITE XL BLOOD LANCET (August 1, 1990)

Other clearances for product code FMI

  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)

FDA data resources