FDA product code NOY

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Gastroenterology, Urology·Class 2·21 CFR 876.5550·Implantable
US regulatory classifications
US Product Code (FDA)
NOY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5550
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).

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About this record

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia 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.