Focus Surgery, Inc.

FDA Device Registration & Listing · Indianapolis, IN, US · Registration 2951226

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2951226
FEI Number
3002132857
Entity Name
Focus Surgery, Inc.
City/State/Country
Indianapolis, IN, US
Establishment Address
4000 Pendleton Way, Indianapolis, IN 46226, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sonablate Corp. (FKA) SonaCare Medical, LLC (Owner Number: 10040576)
Owner / Operator Contact Address
10130 Perimeter Parkway, Suite 410, Charlotte, NC 28216, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K160942
PMA Number
N/A

All Registered Proprietary Names

Sonablate Sonablate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Gastroenterology, Urology Class 2 876.4340 2015-10-22
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Gastroenterology, Urology Class 2 876.4340 2017-01-07

Official Correspondent

Justin Fortner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sonablate Corp. (FKA) SonaCare Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007126306 Sonablate Corp. (FKA) SonaCare Medical, LLC Charlotte, NC, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2951226. Last updated year: 2026. Please use registration number 2951226 when referencing this establishment in official correspondence.
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