K231378 is an FDA 510(k) clearance for the Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0. This device is classified as a High Intensity Ultrasound System For Prostate Tissue Ablation (Class II - Special Controls, product code PLP).
Submitted by Insightec , Ltd. (Tirat-Hacarmet, IL). The FDA issued a Cleared decision on October 30, 2023, 171 days after receiving the submission on May 12, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4340. Prostate Tissue Ablation.
| 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 |
| Product Code | PLP - High Intensity Ultrasound System For Prostate Tissue Ablation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4340 |
| Definition | Prostate Tissue Ablation |