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Disposable 1CC Syringe with Luer Lock

by Interventional Therapeutics Corp.

510(k) K945588

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945588 Date10 Feb 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a disposable syringe classified under product code FMF, designed for single-use administration or aspiration of fluids. The 1cc capacity and Luer Lock connector ensure secure attachment to compatible needles or tubing, reducing the risk of accidental disconnection. It is intended for general medical, laboratory, or veterinary use where precise fluid measurement and transfer are required.

The syringe is supplied as a sterile, single-use item, individually packaged to maintain sterility until first use. It complies with FDA 510(k) clearance (K945588) under the Traditional review pathway, classified as substantially equivalent to predicate devices. No MRI safety information is specified, and it is intended for use in clinical or procedural settings where aseptic technique is mandatory. Storage should follow manufacturer guidelines to preserve sterility and functionality.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 1cc Luer Lock syringe designed for?

    This disposable 1cc syringe with Luer Lock is intended for single-use administration or aspiration of fluids in clinical, laboratory, or veterinary settings. Its precise 1cc capacity and secure Luer Lock connector make it ideal for tasks requiring accurate fluid measurement and transfer, such as injections, sample collection, or irrigation procedures.

  • How is the syringe supplied and what does sterility mean for its use?

    The syringe is supplied as a sterile, single-use item in individually packaged form to maintain sterility until first use. Sterility ensures it is free from harmful microorganisms, which is critical for medical procedures where aseptic technique is mandatory to prevent infection or contamination.

  • Is this syringe reusable or meant for single-use only?

    This syringe is explicitly designed for single-use only. After use, it should be discarded to avoid cross-contamination and maintain compliance with infection control protocols. Reuse could compromise sterility and integrity, posing risks to patient safety.

  • What storage instructions should be followed to preserve its functionality?

    The syringe should be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Typically, this means keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

  • Does this syringe have any special compatibility requirements with needles or tubing?

    The Luer Lock connector on this syringe is designed for secure attachment to compatible needles or tubing, reducing the risk of accidental disconnection during use. Ensure the needle or tubing you attach has a matching Luer Lock fitting to maintain a tight seal and prevent leaks.