OEK — Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia Class II
FDA product code OEK covers "Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia", a Class II medical device regulated under 21 CFR 876.4300. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- OEK
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia