Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
FDA 510(k) clearance K231378 · decided 2023-10-30
Clearance details
- K-number
- K231378
- Device name
- Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
- Applicant
- Insightec, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-12
- Decision date
- 2023-10-30
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- PLP
- Device class
- 2
- Regulation number
- 876.4340
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tirat-Hacarmet, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Focal One® (K251910) | Edap Technomed, Inc. | 2025-11-19 |
| Tulsa Pro System (Pad-105) (K240296) | Profound Medical, Inc. | 2024-05-09 |
| TULSA-PRO System (K230692) | Profound Medical, Inc. | 2023-09-20 |
| TULSA-PRO System (K211858) | Profound Medical, Inc. | 2022-09-06 |
| Exablate Prostate System (K212150) | Insightec, Inc. | 2021-11-23 |
| Tulsa-Pro System (K202286) | Profound Medical, Inc. | 2020-09-16 |
| TULSA-PRO System (K191200) | Profound Medical, Inc. | 2019-08-15 |
| FOCAL ONE (K172721) | Edap Technomed, Inc. | 2018-06-07 |
| Ablatherm Fusion (K172285) | Edap Technomed, Inc. | 2017-10-03 |
| Sonablate (K160942) | Sonacare Medical, LLC | 2016-12-21 |
| Ablatherm Integrated Imaging (K153023) | Edap Technomed, Inc. | 2015-11-06 |
| Sonablate 450 (DEN150011) | Sonacare Medical, LLC | 2015-10-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Exablate 2000 System Magnetic Resonance Guided Focused Ultrasound Ablation of Uterine Fibroids (P040003/S022) | Insightec, Ltd. | 2025-07-23 |
| Exablate 2100/2100V1 System (P040003/S021) | Insightec, Ltd. | 2018-08-16 |
| InSightec ExAblate System (P040003/S019) | Insightec, Ltd. | 2016-10-28 |
| EXABLATE 2000 SYSTEM (P040003/S018) | Insightec, Ltd. | 2016-08-26 |
| EXABLATE 2000 SYSTEM (P040003/S017) | Insightec, Ltd. | 2016-06-27 |
| EXABLATE (P040003/S016) | Insightec, Ltd. | 2015-10-05 |
| EXABLATE (P040003/S015) | Insightec, Ltd. | 2015-08-31 |
| EXABLATE SYSTEM (P040003/S014) | Insightec, Ltd. | 2014-06-13 |