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by Steritec Products Mfg Co, Inc.

510(k) K972300

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 NumberK972300 Date25 Mar 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1532-2010 FDA Unclassified (pre-2012) initiated 15 Jul 2009

    This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their products. There is insufficient data on file to support the shelf life dating on the product labeling.

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  • Withdrawn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
JOJ
Device Class
Class II
Regulation
21 CFR Part 880.2800
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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