Clearance Summary
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 received FDA 510(k) clearance under submission number K231378, sponsored by Insightec, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2023-10-30.
- Submission: K231378
- Applicant / Sponsor: Insightec, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4340
- Decision date: 2023-10-30
Classification & Regulation
This clearance is catalogued under FDA product code PLP and 21 CFR 876.4340, within the Gastroenterology, Urology review panel as a Class II device.