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Spungard & Surg. Drapes-Gowns & Packs

by Kimberly-Clark Corp.

510(k) K842115

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 NumberK842115 Date11 Jun 1984ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0257-2013 FDA Class II initiated 5 Jul 2012

    Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

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  • Withdrawn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
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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