LMF · Agent, Absorbable Hemostatic, Collagen Based
General, Plastic Surgery · 21 CFR 878.4490 · Class 3
Overview
| Product Code | LMF |
|---|---|
| Device Name | Agent, Absorbable Hemostatic, 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.
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P990004 | SURGIFOAM ABSORBABLE GELATIN SPONGE, USP | Ferrosan Meidcal Devices A/S | Sep 30, 1999 | APPR |
| P930030 | HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE | Coletica S.A. | Aug 15, 1995 | APWD |
| P850023 | HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT | Datascope Corp. | May 27, 1986 | APWD |
| P850010 | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE | Integra LifeSciences Corporation | Nov 8, 1985 | APPR |
| P830079 | INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT | ETHICON, Inc. | Oct 10, 1985 | APWD |
| N18286 | GELFOAM | Pfizer, Inc. | Jul 8, 1983 | APPR |
| P810040 | SUPERSTAT | Superstat Corp. | Jan 29, 1982 | APPR |
| P810006 | COLLASTAT | Integra LifeSciences Corporation | Dec 10, 1981 | APPR |
| P800002 | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB | C.R. Bard, Inc. | Oct 24, 1980 | APPR |
| N17600 | 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
