Identifiers
- 510(k) Number
- K212150 FDA 510(k)
- FDA Product Code
- PLP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4340 FDA 510(k)
- Regulation Number
- 876.4340 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Exablate Prostate System is a High Intensity Ultrasound System For Prostate Tissue Ablation. It utilizes focused ultrasound to treat prostate tissue without surgical incisions or radiation, with procedure guidance provided by MRI imaging for precise treatment planning.
The system is supplied as a reusable device and is intended for use in clinical settings under the supervision of trained healthcare professionals. It has received FDA 510(k) clearance (K212150) and is classified as a Class II medical device under regulation number 876.4340, with product code PLP and medical specialty in Gastroenterology and Urology.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Nadir Alikacem VP Regulated Clinical Affairs (US Agent) Insightec, Inc ..., Exablate solutions for healthcare professionals | Insightec, EXABLATE PROSTATE - InSightec - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212150 | Class II | Active |
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Manufacturer
- Manufacturer
- Insightec, Inc.
Sources (1)
- FDA 510(k) K212150 24 fields · synced Sep 22, 2026