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FDA 510(k)

PISTON SYRINGE

K-Number: K961877 · 1996-08-07

ApplicantUnivec, Inc.
Decision Date1996-08-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PISTON 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 1996-08-07 under 510(k) number K961877. 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 PISTON SYRINGE?

PISTON SYRINGE is a medical device that received FDA 510(k) clearance on 1996-08-07. The listed applicant is Univec, Inc.. The 510(k) number is K961877.

When did PISTON SYRINGE receive FDA 510(k) clearance?

PISTON SYRINGE received FDA 510(k) clearance on 1996-08-07, under 510(k) number K961877.

Who is the listed applicant for PISTON 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 PISTON SYRINGE?

The FDA product code for PISTON SYRINGE is FMI.

Related Clinical Trials

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Other records listing Univec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K020500UNIVEC BIFURCATED SLIDING SHEATH SYRINGEK993996UNIVEC AUTO-DISABLE HYPODERMIC SYRINGEK000747UNIVEC TWO PIECE SYRINGEK933469UNIVEC NON-REUSABLE SYRINGEK951619UNIVEC NONREUSABLE LOCKING SYRINGEK943679UNIVEC NONRESUSABLE LOCKING SYRINGE

View all 7 devices →

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed 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.

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