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) → LMG — Agent, Absorbable Hemostatic, Non-Collagen Based

# LMG · Agent, Absorbable Hemostatic, Non-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/LMG

## Overview

- **Product Code:** LMG
- **Device Name:** Agent, Absorbable Hemostatic, Non-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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P210036](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMG/P210036.md) | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | May 19, 2023 | APPR |
| [P050038](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMG/P050038.md) | ARISTA AH ABSORBABLE HEMOSTAT | Davol, Inc. | Sep 26, 2006 | APPR |
| [N12159](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/LMG/N12159.md) | SURGICEL BRAND ABSORBABLE HEMOSTAT | ETHICON, Inc. | Oct 14, 1960 | APPR |

## Top Applicants

- Baxter Healthcare Corporation — 1 clearance
- Davol, Inc. — 1 clearance
- ETHICON, Inc. — 1 clearance

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

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