Cleared Traditional

K231378 - Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231378 · Insightec , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
171d
Days
Class 2
Risk

K231378 is an FDA 510(k) clearance for the Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 21.... Classified as High Intensity Ultrasound System For Prostate Tissue Ablation (product code PLP), Class II - Special Controls.

Submitted by Insightec , Ltd. (Tirat-Hacarmet, IL). The FDA issued a Cleared decision on October 30, 2023 after a review of 171 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4340 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Insightec , Ltd. devices

Submission Details

510(k) Number K231378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2023
Decision Date October 30, 2023
Days to Decision 171 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 130d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4340
Definition Prostate Tissue Ablation
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Insightec, Inc.
Nadir Alikacem

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PLP High Intensity Ultrasound System For Prostate Tissue Ablation

All 12
Devices cleared under the same product code (PLP) and FDA review panel - the closest regulatory comparables to K231378.
Focal One®
K251910 · Edap Technomed, Inc. · Nov 2025
Tulsa Pro System (Pad-105)
K240296 · Profound Medical, Inc. · May 2024
TULSA-PRO System
K230692 · Profound Medical, Inc. · Sep 2023
TULSA-PRO System
K211858 · Profound Medical, Inc. · Sep 2022
Exablate Prostate System
K212150 · InSightec, Inc. · Nov 2021