Product code OEK
- Device name
- Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4300
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Thermotherapy and dilation of prostatic tissue for the treatment of benign prostatic hyperplasia
- Source
- FDA openFDA device classification dataset