FDA product code PNB

Biliary Stent System For Benign Strictures

Gastroenterology, Urology·Class 2·21 CFR 876.5011·Implantable
US regulatory classifications
US Product Code (FDA)
PNB
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5011
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.

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About this record

Biliary Stent System For Benign Strictures 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. This device type includes implantable products.

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.