510(k) Report

FDA applicant

Sonacare Medical, LLC

Charlotte, NC2 decisions2015–20160 recalls

FDA records 2 decisions for Sonacare Medical, LLC (Charlotte, NC) from 2015 to 2016: 1 510(k) clearance and 1 De Novo grant. All are in product code PLP (High Intensity Ultrasound System For Prostate…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Sonacare Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Sonacare Medical, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation2decisions

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160942SonablateSonacare Medical, LLC · 20163cite it
  • DEN150011Sonablate 450Sonacare Medical, LLC · 20151cites it

What has FDA decided for it lately?

  • K160942SonablateSonacare Medical, LLC · 2016
  • DEN150011Sonablate 450Sonacare Medical, LLC · 2015

All 2 as Sonacare Medical, LLC →