Dukal 5501
by Dukal LLC
Dukal 5501 is a Class II device made by Dukal LLC, cleared under FDA 510(k) K221999 on 30 Aug 2022 and listed in FDA GUDID since 12 Jan 2026 (UDI-DI 10665973032648), 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 | Number10665973032648 | Date12 Jan 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221999 | Date30 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 10665973032648
- FDA 510(k) database K221999
Across registries
- FDA 510(k) K221999 decided 30 Aug 2022 Active
- FDA GUDID UDI-DI 10665973032648 listed 12 Jan 2026 Listed
Timeline
- Cleared FDA 510(k) K221999
- Listed FDA GUDID 10665973032648
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dukal
- Generic name
- Skin topical coupling gel
- Model / Ref / Catalog
- 5501
- Description
- Ultrasound Transmission Gel , 20g , Sterile
- Primary DI / UDI-DI
- 10665973032648
- 510(k) Number
- FDA product code
- MUI
- GMDN term
- Skin topical coupling gel
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
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- ULTRAEKOGEL MODELS EK 2000 & EK 2001 by Inmed Ltda.