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510(k) K840033

HYPODERMIC NEEDLES & STYLETS by Microvasive — Product Code FMI

K840033 is an FDA 510(k) premarket notification submitted by Microvasive for the device "HYPODERMIC NEEDLES & STYLETS". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Microvasive has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
January 5, 1984
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 Microvasive

  • K872771 — LOW PROFILE GASTROSTOMY (October 9, 1987)
  • K870705 — THERMAL COAGULATOR (April 17, 1987)
  • K861309 — JEJUNAL FEEDING TUBE (December 16, 1986)
  • K861323 — REPLACEMENT GASTROSTOMY TUBE (December 16, 1986)
  • K860366 — CHALLENGER HOT BIOPSY FORCEPS (April 7, 1986)
  • K860589 — INFLATOR/DEFLATOR PISTON SYRINGE (April 7, 1986)
  • K854238 — NEEDLE W/STYLET FOR IMPLANTATION (November 13, 1985)
  • K854063 — MICROVASIVE SILICONE SPRAY (October 25, 1985)
  • K851652 — PAPILLOTOME (June 24, 1985)
  • K850393 — FLEXIBLE FIBEROPTIC ENDOSCOPE (June 4, 1985)

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