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Gelfoam Sterile Sponge

by Pfizer Inc. PMA

Active United States

PMA N18286

Overview

Gelfoam Sterile Sponge is an absorbable hemostatic agent made from collagen, intended for application to bleeding surfaces to achieve hemostasis. It is a sterile, water-insoluble, off-white sponge designed for use in general and plastic surgery procedures.

The device is supplied sterile and is intended for single-use application. It is regulated as a Class III device under FDA PMA N18286 with product code LMF. No MRI safety, storage, or size specifications are provided in the source data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberN18286 Date8 Jul 1983ApprovedStatusActive

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Trade Name
Gelfoam
Generic Name
Agent, absorbable hemostatic, collagen based
FDA applicant
Pfizer, Inc.
PMA Number
FDA Product Code
LMF
Device Class
Class III
Regulation
21 CFR Part 878.4490
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

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Questions

  • What is Gelfoam Sterile Sponge made of?

    Gelfoam Sterile Sponge is made from an absorbable collagen-based material, as specified in its generic name: Agent, absorbable hemostatic, collagen based.

  • Is Gelfoam Sterile Sponge sterile and for single use?

    Yes, the device is supplied sterile and is intended for single-use application to bleeding surfaces as a hemostatic agent.

  • What regulatory authorization does Gelfoam Sterile Sponge have?

    Gelfoam Sterile Sponge has FDA PMA authorization under application number N18286 and is classified as a Class III device with product code LMF.