Sonablate Corp. (FKA) SonaCare Medical, LLC

FDA Device Registration & Listing · Charlotte, NC, US · Registration 3007126306

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
3007126306
FEI Number
3007126306
Entity Name
Sonablate Corp. (FKA) SonaCare Medical, LLC
City/State/Country
Charlotte, NC, US
Establishment Address
10130 Perimeter Parkway Ste 410, Charlotte, NC 28216, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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
DEN150011
PMA Number
N/A

All Registered Proprietary Names

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

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
2951226 Focus Surgery, Inc. Indianapolis, IN, US

Similar Registrations

Registration Number Establishment Name Location
9615058 INSIGHTEC, LTD. TIRAT CARMEL Haifa, IL
1450662 Isomedix Operations, Inc. Libertyville, IL, US
2951226 Focus Surgery, Inc. Indianapolis, IN, US
3012604011 PROFOUND MEDICAL INC. Mississauga Ontario, CA
1319639 Sterigenics U.S., LLC Queensbury, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007126306. Last updated year: 2026. Please use registration number 3007126306 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.