Argyle 8810807001
Argyle 8810807001 is a Class II device made by Mozarc Medical US LLC, cleared under FDA 510(k) K780449 on 16 May 1978 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 10884521003927), 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 | Number10884521003927 | Date22 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK780449 | Date16 May 1978 | StatusActive |
Official records
- AccessGUDID record 10884521003927
- FDA 510(k) database K780449
Across registries
- FDA 510(k) K780449 decided 16 May 1978 Active
- FDA GUDID UDI-DI 10884521003927 listed 22 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K780449
- Listed FDA GUDID 10884521003927
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Argyle
- Generic name
- Medical device adhesive
- Model / reference
- 8810807001
- Primary DI / UDI-DI
- 10884521003927
- 510(k) Number
- FDA product code
- FJS
- GMDN term
- Medical device adhesive
- Device class
- Class II
- Regulation number
- 876.5630
- GUDID distribution status
- In Commercial Distribution
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