FDA 510(k)

UNIVEC NONRESUSABLE LOCKING SYRINGE

K-Number: K943679 · 1994-12-12

Decision Date1994-12-12

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

UNIVEC NONRESUSABLE LOCKING SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Univec, Inc.. It received FDA 510(k) clearance on 1994-12-12 under 510(k) number K943679. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVEC NONRESUSABLE LOCKING SYRINGE?

UNIVEC NONRESUSABLE LOCKING SYRINGE is a medical device that received FDA 510(k) clearance on 1994-12-12. The listed applicant is Univec, Inc.. The 510(k) number is K943679.

When did UNIVEC NONRESUSABLE LOCKING SYRINGE receive FDA 510(k) clearance?

UNIVEC NONRESUSABLE LOCKING SYRINGE received FDA 510(k) clearance on 1994-12-12, under 510(k) number K943679.

Who is the listed applicant for UNIVEC NONRESUSABLE LOCKING SYRINGE?

The FDA 510(k) record lists Univec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVEC NONRESUSABLE LOCKING SYRINGE?

The FDA product code for UNIVEC NONRESUSABLE LOCKING SYRINGE is FMI.

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Other records listing Univec, Inc. as applicant

K020500UNIVEC BIFURCATED SLIDING SHEATH SYRINGE K993996UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE K000747UNIVEC TWO PIECE SYRINGE K961877PISTON SYRINGE K933469UNIVEC NON-REUSABLE SYRINGE K951619UNIVEC NONREUSABLE LOCKING SYRINGE

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Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.