The following data is part of a De Novo classification by Sonacare Medical, Llc. with the FDA for Sonablate 450.
| DeNovo ID | DEN150011 |
| Device Name: | Sonablate 450 |
| Classification | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Applicant | SonaCare Medical, LLC. 801 E. Morehead St suite 201 Charlotte, NC 28202 |
| Contact | Dawn Byrd Burleson |
| Product Code | PLP |
| CFR Regulation Number | 876.4340 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2015-03-23 |
| Decision Date | 2015-10-09 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868108000274 | DEN150011 | 000 |