510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150011Unknown

Sonablate 450

Sonacare Medical, LLC, Charlotte NC / Direct, Unknown
FDA source (opens on fda.gov)

DEN150011 is the FDA 510(k) clearance record for Sonablate 450, a class II device, cleared for Sonacare Medical, LLC on under FDA product code PLP (High Intensity Ultrasound System For Prostate Tissue Ablation). FDA's definition for product code PLP reads: "Prostate tissue ablation". FDA records list 2 510(k) clearances for Sonacare Medical, LLC, from to . As of , FDA records show no recalls naming DEN150011.

Clearance record

Decision date
Received
(200 days to decision)
Product code
PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Regulation
21 CFR 876.4340
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sonacare Medical, LLC 801 E. Morehead St., Charlotte NC
Third party review
No

Clearances, product code PLP

Trailing 12 months
1 clearance under product code PLP in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PLP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260