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510(k) K830242

MICRO 2 HYPODERMIC NEEDLES by Smith & Nephew, Mpl Division — Product Code FMI

K830242 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Mpl Division for the device "MICRO 2 HYPODERMIC NEEDLES". The FDA issued a decision of Substantially Equivalent on February 15, 1983. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Smith & Nephew, Mpl Division has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1983
Date Received
January 25, 1983
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 Smith & Nephew, Mpl Division

  • K843314 — MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE (September 27, 1984)
  • K841280 — SOLOPAK BRAND FILTER NEEDLE W/5 MICRO (May 21, 1984)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K833304 — HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST (March 30, 1984)
  • K832126 — MICRO Z DISPOS. SPINAL ANESTH. NEEDLE (August 12, 1983)
  • K831765 — HERAPIN LOCK FLUSH SOLUTION USE KIT (July 12, 1983)
  • K830524 — HENKE JECT PRESSURE SYRINGE (March 24, 1983)
  • K761206 — INTEROSSEOUS NEEDLE (December 13, 1976)

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