Exablate Prostate System— 510(k) K212150
Substantially EquivalentInsightec, Inc.
FDA 510(k) clearance K212150 for Exablate Prostate System, Substantially Equivalent on 2021-11-23. Applicant: Insightec, Inc.. Device class: 2.
Clearance details
- Applicant
- Insightec, Inc.
- Product code
- Code PLP
- Device class
- Class 2
- Regulation
- 21 CFR 876.4340
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code PLP
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