510(k) DEN210027
DEN210027 is an FDA 510(k) premarket notification submitted by Braincool AB for the device "The Cooral System". The FDA issued a decision of De Novo Granted on October 14, 2022. The device falls under product code QUA (Intraoral Cooling Device), a Class II device regulated under 21 CFR 872.5590. Braincool AB has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 14, 2022
- Date Received
- July 2, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoral Cooling Device
- Device Class
- Class II
- Regulation Number
- 872.5590
- Review Panel
- DE
- Submission Type
An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces