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Simplastin Excel S

by Organon Teknika Corp.

510(k) K882214

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 NumberK882214 Date1 Jul 1988ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0628-03 FDA Unclassified (pre-2012) initiated 23 Dec 2002

    Vial to vial variability which can result in prolonged clot times.

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  • Withdrawn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
GJS
Device Class
Class II
Regulation
21 CFR Part 864.7750
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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