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ProgenaMatrix

by Cell Constructs I, LLC

510(k) K182010

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 NumberK182010 Date17 Jan 2019ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1137-2022 FDA Class II initiated 18 Apr 2022

    Inner pouch seal may be inadequate resulting in lack of sterility.

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  • Withdrawn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
KGN
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent