FDA product code OEJ
Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia
Gastroenterology, Urology·Class 2·21 CFR 876.4300
US regulatory classifications
- US Product Code (FDA)
- OEJView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 876.4300View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia
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About this record
Transurethral Electrosurgical Unit, 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.
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.