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Sologuard Locking Plus Syringe

by Safeguard Medical Products, Inc.

510(k) K993609

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 NumberK993609 Date17 Mar 2000ClearedStatusActive

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  • Withdrawn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
MEG
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Sologuard Locking Plus Syringe is a sterile, single-use, disposable hypodermic syringe designed with an integrated plunger locking mechanism to prevent accidental reuse. It is classified as an antistick syringe and is intended for intravenous, intramuscular, or subcutaneous injections, ensuring secure medication delivery while mitigating reuse risks.

This syringe is supplied without a needle and features a LuerLock connector. Available in sizes of 1 mL, 2.5 mL, 3 mL, 5 mL, and 10 mL, it is intended for single-use in clinical settings. The device has received FDA 510(k) clearance under the Traditional review pathway, with a classification of Class II (MEG product code). It is non-sterile upon packaging and must be sterilized prior to use.