Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4490](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4490) → LMF — Agent, Absorbable Hemostatic, Collagen Based

# LMF · Agent, Absorbable Hemostatic, Collagen Based

_General, Plastic Surgery · 21 CFR 878.4490 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF

## Overview

- **Product Code:** LMF
- **Device Name:** Agent, Absorbable Hemostatic, Collagen Based
- **Regulation:** [21 CFR 878.4490](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4490)
- **Device Class:** 3
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.

## Classification Rationale

Class III.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P990004](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P990004.md) | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | Sep 30, 1999 | APPR |
| [P930030](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P930030.md) | HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE | Coletica S.A. | Aug 15, 1995 | APWD |
| [P850023](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P850023.md) | HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT | Datascope Corp. | May 27, 1986 | APWD |
| [P850010](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P850010.md) | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE | Integra LifeSciences Corporation | Nov 8, 1985 | APPR |
| [P830079](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P830079.md) | INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT | ETHICON, Inc. | Oct 10, 1985 | APWD |
| [N18286](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/N18286.md) | GELFOAM | Pfizer, Inc. | Jul 8, 1983 | APPR |
| [P810040](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P810040.md) | SUPERSTAT | Superstat Corp. | Jan 29, 1982 | APPR |
| [P810006](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P810006.md) | COLLASTAT | Integra LifeSciences Corporation | Dec 10, 1981 | APPR |
| [P800002](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/P800002.md) | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB | C.R. Bard, Inc. | Oct 24, 1980 | APPR |
| [N17600](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF/N17600.md) | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) | Davol Inc., Sub. C. R. Bard, Inc. | Aug 26, 1976 | APPR |

## Top Applicants

- Integra LifeSciences Corporation — 2 clearances
- Superstat Corp. — 1 clearance
- Pfizer, Inc. — 1 clearance
- Ferrosan Meidcal Devices A/S — 1 clearance
- ETHICON, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMF)

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