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510(k) K895769

EXEL HUBER NEEDLE by Exel Intl. — Product Code FMI

K895769 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL HUBER NEEDLE". The FDA issued a decision of Substantially Equivalent on February 16, 1990. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Exel Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
September 26, 1989
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 Exel Intl.

  • K992290 — EXEL INJECTION PLUG WITH CAP (February 23, 2000)
  • K963658 — EXEL AVF SINGLE NEEDLE (May 5, 1998)
  • K963659 — EXEL I.V. ADMINISTRATION SET (December 16, 1997)
  • K926119 — EXEL HUBER INFUSION SET ROTATING WING (August 11, 1993)
  • K904685 — EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) (November 21, 1990)
  • K903945 — EXEL A-V FISTULA SET (November 20, 1990)
  • K895770 — EXEL HUBER INFUSION SET (July 19, 1990)
  • K895771 — EXEL SPINAL NEEDLES (February 16, 1990)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 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