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DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive

by Ethicon Inc.

510(k) K152096

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 NumberK152096 Date22 Oct 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0953-2021 FDA Class II initiated 4 Jan 2021

    Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

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  • Withdrawn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
MPN
FDA applicant
ETHICON, Inc.
Device Class
Class II
Regulation
21 CFR Part 878.4010
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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