Sonablate
High Intensity Ultrasound System For Prostate Tissue Ablation
SonaCare Medical, LLC
The following data is part of a premarket notification filed by Sonacare Medical, Llc with the FDA for Sonablate.
Pre-market Notification Details
| Device ID | K160942 |
| 510k Number | K160942 |
| Device Name: | Sonablate |
| Classification | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Applicant | SonaCare Medical, LLC 10130 PERIMETER PARKWAY, SUITE 250 Charlotte, NC 28216 |
| Contact | David M. Hernon |
| Correspondent | David M. Hernon SONACARE MEDICAL, LLC 10130 PERIMETER PARKWAY, SUITE 250 Charlotte, NC 28216 |
| Product Code | PLP |
| CFR Regulation Number | 876.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-12-21 |
Trademark Results [Sonablate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONABLATE 77239670 3552645 Live/Registered |
THS International, Inc. 2007-07-26 |
 SONABLATE 75775384 2532689 Dead/Cancelled |
Focus Surgery 1999-09-09 |
 SONABLATE 74390697 not registered Dead/Abandoned |
DIASONICS, INC. 1993-05-14 |
 SONABLATE 74223406 not registered Dead/Abandoned |
DIASONICS, INC. 1991-11-18 |
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