FDA Product Code
FDA Product Code PLP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4340
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251910 | Focal One® | Edap Technomed, Inc. | 2025-11-19 | Traditional | PDF ↗ |
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical, Inc. | 2024-05-09 | Traditional | PDF ↗ |
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Insightec, Ltd. | 2023-10-30 | Traditional | PDF ↗ |
| K230692 | TULSA-PRO System | Profound Medical, Inc. | 2023-09-20 | Traditional | PDF ↗ |
| K211858 | TULSA-PRO System | Profound Medical, Inc. | 2022-09-06 | Traditional | PDF ↗ |
| K212150 | Exablate Prostate System | Insightec, Inc. | 2021-11-23 | Traditional | PDF ↗ |
| K202286 | Tulsa-Pro System | Profound Medical, Inc. | 2020-09-16 | Special | PDF ↗ |
| K191200 | TULSA-PRO System | Profound Medical, Inc. | 2019-08-15 | Traditional | PDF ↗ |
| K172721 | FOCAL ONE | Edap Technomed, Inc. | 2018-06-07 | Traditional | PDF ↗ |
| K172285 | Ablatherm Fusion | Edap Technomed, Inc. | 2017-10-03 | Traditional | PDF ↗ |
| K160942 | Sonablate | Sonacare Medical, LLC | 2016-12-21 | Traditional | PDF ↗ |
| K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015-11-06 | Traditional | PDF ↗ |
| DEN150011 | Sonablate 450 | Sonacare Medical, LLC | 2015-10-09 | Direct | — |
Product code PLP · Class II · Gastroenterology, Urology. Data: openFDA.