510(k) K232917
K232917 is an FDA 510(k) premarket notification submitted by Chemo Mouthpiece, LLC for the device "Chemo Mouthpiece". The FDA issued a decision of Substantially Equivalent on January 23, 2024. The device falls under product code QUA (Intraoral Cooling Device), a Class II device regulated under 21 CFR 872.5590.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2024
- Date Received
- September 19, 2023
- Clearance Type
- Traditional
- 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