Dukal 5157
by Dukal LLC
Dukal 5157 is a Class I device made by Dukal LLC, cleared under FDA 510(k) K931005 on 14 Jul 1993 and listed in FDA GUDID since 6 Dec 2022 (UDI-DI 10665973008810), 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 | Number10665973008810 | Date6 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK931005 | Date14 Jul 1993 | StatusActive |
Official records
- AccessGUDID record 10665973008810
- FDA 510(k) database K931005
Across registries
- FDA 510(k) K931005 decided 14 Jul 1993 Active
- FDA GUDID UDI-DI 10665973008810 listed 6 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K931005
- Listed FDA GUDID 10665973008810
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dukal
- Generic name
- Skin-closure adhesive strip
- Model / Ref / Catalog
- 5157
- Primary DI / UDI-DI
- 10665973008810
- 510(k) Number
- FDA product code
- FPX
- GMDN term
- Skin-closure adhesive strip
- Device class
- Class I
- Regulation number
- 880.5240
- GUDID distribution status
- In Commercial Distribution
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