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SCSClass II

Ultraviolet Radiation Disinfection Chamber Device

21 CFR 880.6511 / General Hospital
FDA source (opens on fda.gov)

SCS is the FDA product code for Ultraviolet Radiation Disinfection Chamber Device, a class II device type, regulated under 21 CFR 880.6511. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SCS
Device name
Ultraviolet Radiation Disinfection Chamber Device
FDA 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.
Regulation
21 CFR 880.6511
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SCS

By decision year
2 clearances under product code SCS with a decision year between 2024 and 2026, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SCS by decision year
YearClearances
20241
20261

Applicants with the most clearances

Product code SCS
Applicants holding the most 510(k) clearances under product code SCS
ApplicantClearances
Germitec1
UV Smart Technologies B.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code