HELICOLL HC2x4
by Encoll Corp.
HELICOLL HC2x4 is a device classified as Unclassified made by Encoll Corp., cleared under FDA 510(k) K040314 on 12 Aug 2004 and listed in FDA GUDID since 11 Jul 2020 (UDI-DI 10860000744413), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10860000744413 | Date11 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040314 | Date12 Aug 2004 | StatusActive |
Official records
- AccessGUDID record 10860000744413
- FDA 510(k) database K040314
Across registries
- FDA 510(k) K040314 decided 12 Aug 2004 Active
- FDA GUDID UDI-DI 10860000744413 listed 11 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K040314
- Listed FDA GUDID 10860000744413
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Helicoll
- Generic name
- Animal-derived wound matrix dressing
- Model / Ref / Catalog
- HC2x4
- Primary DI / UDI-DI
- 10860000744413
- 510(k) Number
- FDA product code
- KGN
- GMDN term
- Animal-derived wound matrix dressing
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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