Skintemp II
510(k) K122325
Skintemp II is a device classified as Unclassified made by Human Biosciences Inc., cleared under FDA 510(k) K122325 on 26 Oct 2012, active as of 8 Nov 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 | NumberK122325 | Date26 Oct 2012 | StatusActive |
Official records
- FDA 510(k) database K122325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KGN
- FDA applicant
- Human Biosciences, Inc.
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K122325
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 | |||
|---|---|---|---|---|
| CURCO FR1011 | FR1011 | 00850084084010 | On the market | |
| CURCO FR1014 | FR1014 | 00850084084058 | On the market | |
| CURCO FR1022 | FR1022 | 00850084084027 | On the market | |
| CURCO FR1044 | FR1044 | 00850084084034 | On the market | |
| CURCO FR1077 | FR1077 | 00850084084041 | On the market | |
| CURCO FR1110 | FR1110 | 00850084084065 | On the market | |
| CURCO FR1210 | FR1210 | 00850084084072 | On the market | |
| Nuvagen Collagen Dressing 1002 | 1002 / 1002 | 00618474000527 | No longer on the market | |
| Zeni Medical 90022 | 90022 | 00324357900227 | On the market | |
| Zeni Medical 90044 | 90044 | 00324357900449 | On the market |
Similar devices
Other devices filed under FDA product code KGN (Wound Dressing With Animal-Derived Material(S)).
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- Device 104 Particulate by Geistlich Pharma AG
- ACELL UBM HYDRATED WOUND DRESSING by ACELL, INC.
- INTEGRA Wound Matrix (Macro-Channels) by Integra Lifesciences Corporation
- AONGEN COLLAGEN MATRIX by Aeon Astron Europe B.V.
- MicroMatrix by ACELL, INC.
- BIOBRANE Temporary Wound Dressing; BIOBRANE Glove by Smith & Nephew Medical, Ltd.