510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212150Substantially Equivalent

Exablate Prostate System

Insightec, Ltd., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212150 is the FDA 510(k) clearance record for Exablate Prostate System, a class II device, cleared for Insightec, Inc. 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 Insightec, Inc., from to . As of , FDA records show no recalls naming K212150.

Clearance record

Decision date
Received
(137 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
Insightec, Inc. 4851 Lbj Fwy., Dallas TX
510(k) summary
Summary PDF
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