FDA product code SCT

Foley Catheters And Accessories With Additional Safety Features

Gastroenterology, Urology·Class 2·21 CFR 876.5130
US regulatory classifications
US Product Code (FDA)
SCT
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5130
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Foley Catheters And Accessories With Additional Safety Features is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.