LMG · Agent, Absorbable Hemostatic, Non-Collagen Based
General, Plastic Surgery · 21 CFR 878.4490 · Class 3
Overview
| Product Code | LMG |
|---|---|
| Device Name | Agent, Absorbable Hemostatic, Non-Collagen Based |
| Regulation | 21 CFR 878.4490 |
| Device Class | Class 3 |
| Review Panel | General, Plastic Surgery |
| 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 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | May 19, 2023 | APPR |
| P050038 | ARISTA AH ABSORBABLE HEMOSTAT | Davol, Inc. | Sep 26, 2006 | APPR |
| N12159 | 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
