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Surgicel

by Ethicon Inc.

PMA N12159

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N12159

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 PMAAPPR Approved 1 supplement NumberN12159 Date2 Feb 1981ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic name
Agent, absorbable hemostatic, non-collagen based
FDA applicant
ETHICON, Inc.
PMA number
FDA product code
LMG
Device class
Class III
Regulation
21 CFR Part 878.4490
Advisory committee
General, Plastic Surgery
FDA decision
APPR Approved
PMA supplement
S002

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.

Surgicel is an absorbable hemostatic agent, non-collagen based, designed to control bleeding in surgical procedures. It is made from oxidized regenerated cellulose and works by promoting blood clot formation at the site of application.

Surgicel is supplied as a sterile, single-use product and is intended for use in general and plastic surgery procedures. The device is FDA PMA approved and should be stored according to the manufacturer's instructions to maintain its integrity and effectiveness.

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Questions

AI-generated answers, 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.

  • What is Surgicel made of?

    Surgicel is made from oxidized regenerated cellulose, which is a plant-derived material that promotes hemostasis through its interaction with blood components.

  • How does Surgicel work to control bleeding?

    Surgicel works by promoting blood clot formation at the site of application. When it comes into contact with blood, it swells and forms a gel-like matrix that helps seal bleeding vessels and provides a framework for clot formation.

  • Is Surgicel reusable or single-use?

    Surgicel is supplied as a sterile, single-use product. It should not be reused as this could compromise its sterility and effectiveness, and potentially introduce infection risks.