MIST 360 Applicator CP-80024
MIST 360 Applicator CP-80024 is a Class II device made by Alliqua Biomedical, Inc., cleared under FDA 510(k) K122246 on 13 Aug 2012 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00816789010242), active as of 22 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 | Number00816789010242 | Date7 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122246 | Date13 Aug 2012 | StatusActive |
Official records
- AccessGUDID record 00816789010242
- FDA 510(k) database K122246
Across registries
- FDA 510(k) K122246 decided 13 Aug 2012 Active
- FDA GUDID UDI-DI 00816789010242 listed 7 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K122246
- Listed FDA GUDID 00816789010242
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MIST 360 Applicator
- Generic name
- Wound therapy ultrasound system handpiece tip
- Model / Ref / Catalog
- CP-80024
- Primary DI / UDI-DI
- 00816789010242
- 510(k) Number
- FDA product code
- NRB
- GMDN term
- Wound therapy ultrasound system handpiece tip
- Device class
- Class II
- Regulation number
- 878.4410
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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