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Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe (5cc Luer Lock)

by Jiangsu Shenli Medical Production Factory

510(k) K103830

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Abbreviated NumberK103830 Date29 Jul 2011ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2940-2024 FDA Class II initiated 24 Jul 2024

    Affected syringes lack FDA clearance.

    • Ongoing Z-3033-2024 FDA Class II initiated 8 Apr 2024

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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  • Withdrawn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