K231378
- 510(k) number
- K231378
- Device name
- Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
- Applicant
- Insightec, Ltd. IL
- Product code
- PLP — High Intensity Ultrasound System For Prostate Tissue
- Decision date
- 2023-10-30
- Date received
- 2023-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231378.pdf
Official FDA record: K231378
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.