PISTON SYRINGE

K961877 · Univec, Inc. · FMI · Aug 7, 1996 · General Hospital

Device Facts

• Record ID: K961877
• Device Name: PISTON SYRINGE
• Applicant: Univec, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Aug 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The UNIVEC Nonreusable Locking Syringe with Coupling Assembly can be used by health care professionals, diabetics and other persons for injection of insulin, tuberculin, immunization serum, and other injectable medications.

Device Story

Single-use piston syringe with integrated coupling assembly; assembly inserted between plunger and rubber stopper; mechanism decouples plunger from stopper after single dosage injection; disables syringe to prevent reuse; operated by healthcare professionals, diabetics, or patients; manual administration of injectable medications; prevents needle stick injuries and reuse; provides safe delivery of insulin, tuberculin, and immunization serum.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piston syringe and hypodermic needle; polypropylene construction; manual energy source; single-use locking mechanism via coupling assembly; non-aspirating design.

Indications for Use

Indicated for health care professionals, diabetics, and other individuals requiring subcutaneous or intramuscular injection of insulin, tuberculin, immunization serum, or other injectable medications.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• UNIVEC Nonreusable Locking Syringe with non-aspirating plunger (K943679)

Submission Summary (Full Text)

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K961877

# 1.0 510(k) SUMMARY

AUG - 7 1996

(1) Submitter’s Information

UNIVEC Inc.
999 Franklin Avenue
Garden City, New York 11530
[phone] (tel)
[phone] (fax)

(2) Device Name

Proprietary Name: UNIVEC Nonreusable Locking Syringe
Common or Usual Names: Piston; Hypodermic Needle
Classification Names: Piston Syringe
21 C.F.R. 880.5680 Class II
Hypodermic single lumen needle
21 C.F.R. 880.5570 Class II

(3) Predicate Device:

K 943679, UNIVEC Nonreusable Locking Syringe with non-aspirating plunger

(4) Description of Device:

The UNIVEC Nonreusable Syringe with Coupling Assembly provides a single use function. This assembly, inserted between the syringe plunger and the syringe rubber stopper, will decouple the plunger from the stopper (and disable the syringe) after injecting one dosage of serum. The assembly materials will be fabricated from the same polypropylene as the syringe.

(5) Statement of Intended Use

The UNIVEC Nonreusable Locking Syringe with Coupling Assembly can be used by health care professionals, diabetics and other persons for injection of insulin, tuberculin, immunization serum, and other injectable medications.

(6) Statement of Technological Characteristics

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The UNIVEC Nonreusable Locking Syringe with Coupling Assembly has no significant change in design, except for the stainless steel locking clip of the predicate. Otherwise, it has the same material, chemical composition, energy source, or other technological characteristics compared to the predicate device listed in paragraph (3).