510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231378Substantially Equivalent

Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

Insightec, Ltd., Tirat-Hacarmet, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231378 is the FDA 510(k) clearance record for Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0, a class II device, cleared for Insightec, Ltd. 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, Ltd., from to . As of , FDA records show no recalls naming K231378.

Clearance record

Decision date
Received
(171 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, Ltd. 5 Nachum Heth St., Tirat-Hacarmet, IL
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