Roosin Collagen Dressing
510(k) K253974
Roosin Collagen Dressing is a device classified as Unclassified made by Roosin Medical Co., Ltd., cleared under FDA 510(k) K253974 on 3 Jun 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253974 | Date3 Jun 2026 | StatusActive |
Official records
- FDA 510(k) database K253974
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KGN
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K253974
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CARBOU U1-20481A | U1-20481A | 00850088144963 | — | On the market |
Similar devices
Other devices filed under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)).
- CUSTOM BURN DRESSING KIT by Hermitage Hospital Products, Inc.
- MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING by Brennen Medical, LLC
- AVAGEN WOUND DRESSING by Integra Lifesciences Corp.
- COLLAGEN WOUND DRESSING by Oasis Research, LLC
- Helios Dermal Scaffold by HELIOS BIOMEDICAL INC.
- neotape by COLLAGEN MATRIX, INC.
- GeniPhys Collymer Self-Assembling Scaffold by Geniphys, Inc.
- EXCELLAGEN by Tissue Repair Company
- PriMatrix® 607-001-009 by TEI BIOSCIENCES INC.
- COLLAGEN WOUND DRESSING - ORAL by COLLAGEN MATRIX, INC.