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Disp. Hypodermic Needle

by Terumo America, Inc.

510(k) K771203

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Traditional NumberK771203 Date14 Jul 1977ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2798-2011 FDA Unclassified (pre-2012) initiated 8 Jun 2010

    Hypodermic needle packaging defect could compromise sterility. Affected lot numbers are: MC1725, MC2025, MC2025

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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