FDA Product Code SCS: Ultraviolet Radiation Disinfection Chamber Device
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.
Leading manufacturers include Germitec and UV Smart Technologies B.V..
FDA 510(k) Cleared Ultraviolet Radiation Disinfection Chamber Device Devices (Product Code SCS)
About Product Code SCS - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SCS since 2024, with 1 receiving FDA clearance (average review time: 305 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SCS devices are reviewed by the General Hospital panel. Browse all General Hospital devices →