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510(k) K961877

PISTON SYRINGE by Univec, Inc. — Product Code FMI

K961877 is an FDA 510(k) premarket notification submitted by Univec, Inc. for the device "PISTON SYRINGE". The FDA issued a decision of Substantially Equivalent on August 7, 1996. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Univec, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1996
Date Received
May 10, 1996
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 Univec, Inc.

  • K020500 — UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (March 19, 2002)
  • K993996 — UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE (July 17, 2000)
  • K000747 — UNIVEC TWO PIECE SYRINGE (June 8, 2000)
  • K933469 — UNIVEC NON-REUSABLE SYRINGE (April 18, 1996)
  • K951619 — UNIVEC NONREUSABLE LOCKING SYRINGE (June 6, 1995)
  • K943679 — UNIVEC NONRESUSABLE LOCKING SYRINGE (December 12, 1994)

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