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DermaBond Topical Skin Adhesive

by Closure Medical Corp.

PMA P960052

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P960052↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP960052 Date26 Aug 1998DecidedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1496-2011 FDA Unclassified (pre-2012) initiated 2 Feb 2011 on shared PMA P960052
    • Terminated Z-1497-2011 FDA Unclassified (pre-2012) initiated 2 Feb 2011 on shared PMA P960052

    Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Dermabond (a Formulation of 2-Octyl Cyanoacrylate)
Generic Name
Tissue adhesive for the topical approximation of skin
PMA Number
FDA Product Code
MPN
Device Class
Class II
Regulation
21 CFR Part 878.4010
Advisory Committee
General, Plastic Surgery
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

DermaBond Topical Skin Adhesive is a tissue adhesive for the topical approximation of skin, classified as a Class II medical device. It is designed to hold closed easily approximated skin edges from surgical incisions, including those from minimally invasive procedures, as well as thoroughly cleansed, trauma-induced lacerations. The adhesive may be used in conjunction with, but not as a substitute for, subcuticular sutures.

This device is supplied as a sterile, single-use topical adhesive and is regulated under FDA Premarket Approval (PMA). It is intended for use in clinical settings where skin closure is required, adhering to FDA’s regulation number 878.4010. The adhesive is packaged for individual use and must be stored according to manufacturer instructions to maintain sterility and efficacy.

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