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Am USA 0.9% Sodium Chloride Flush Syringe

by Am USA 2 variants

510(k) K113555

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 · Special NumberK113555 Date30 Jan 2012ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1174-2024 FDA Class II initiated 28 Dec 2023

    The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.

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  • Withdrawn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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