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SCTClass II

Foley Catheters And Accessories With Additional Safety Features

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

SCT is the FDA product code for Foley Catheters And Accessories With Additional Safety Features, a class II device type, regulated under 21 CFR 876.5130. FDA's definition for this code reads: "Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SCT
Device name
Foley Catheters And Accessories With Additional Safety Features
FDA definition
Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections.
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code