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Disposable Plastic Syringes

by Transcoject GmbH & Co. KG

510(k) K851523

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 NumberK851523 Date24 Jul 1985ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

Disposable plastic syringes are medical devices designed for the administration or withdrawal of fluids. They are constructed from plastic materials and intended for single-use applications.

These syringes are supplied sterile and are used in general hospital settings. They have received FDA 510(k) clearance under product code FMF, with clearance granted on July 24, 1985, under k-number K851523.

Questions

AI-generated answers, 21 Sep 2026

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

  • What are Disposable Plastic Syringes used for?

    Disposable plastic syringes are designed for the administration or withdrawal of fluids in medical procedures. They are intended for single-use applications in general hospital settings, ensuring safe and hygienic handling of liquids during clinical tasks such as injections or fluid aspiration.

  • How are Disposable Plastic Syringes supplied and sterilized?

    These syringes are supplied sterile, meaning they are free from viable microorganisms and ready for immediate use upon opening. The sterile condition is maintained through validated sterilization processes to ensure patient safety during fluid administration or withdrawal.

  • Are Disposable Plastic Syringes reusable or single-use?

    Disposable plastic syringes are explicitly intended for single-use applications only. Reuse is not recommended or supported by the device design, as it may compromise sterility, structural integrity, and patient safety, increasing the risk of cross-contamination or infection.

  • What regulatory clearance do Disposable Plastic Syringes have?

    The Disposable Plastic Syringes have received FDA 510(k) clearance, indicating they are substantially equivalent to a legally marketed predicate device. This clearance was granted on July 24, 1985, under k-number K851523 and product code FMF, allowing their lawful distribution in the United States.