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0.9% Sodium Chloride Flish Syringe

by Am USA

510(k) K120836

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 · Special NumberK120836 Date12 Jul 2012ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2476-2015 FDA Class II initiated 2 Jul 2015

    Procedures for the acceptance and control of in-process product have not been adequately established.

    • Terminated Z-1808-2015 FDA Class II initiated 9 Feb 2015

    Incorrect labeling of the expiration date

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  • Withdrawn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
NGT
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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