Data / Medical devices / United States / Focus Surgery, Inc.
Focus Surgery, Inc.: FDA-registered device maker in Indianapolis, IN, United States, 2 510(k) clearances
Focus Surgery, Inc. is registered with the FDA (registration 2951226) in Indianapolis, IN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 21, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2951226
- FEI number
- 3002132857
- Address
- 4000 Pendleton Way, Indianapolis, IN, United States, 46226
- Owner or operator
- Sonablate Corp. (FKA) SonaCare Medical, LLC (10040576)
- Roles
- Manufacturer
- First device listed
- October 22, 2015
- Registered through
- 2026
- Brand names listed
- Sonablate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| High Intensity Ultrasound System For Prostate Tissue Ablation | PLP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 21, 2016 | K160942 | Sonablate | PLP | Substantially Equivalent | Sonacare Medical, LLC | accessdata.fda.gov |
| October 9, 2015 | DEN150011 | Sonablate 450 | PLP | Unknown | Sonacare Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.