SCS — Ultraviolet Radiation Disinfection Chamber Device Class II
FDA product code SCS covers "Ultraviolet Radiation Disinfection Chamber Device", a Class II medical device regulated under 21 CFR 880.6511. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SCS
- Device Class
- Class II
- Regulation Number
- 880.6511
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.