Tulsa-Pro 106647
Tulsa-Pro 106647 is a medical device (FDA Class II; FDA product code PLP, High Intensity Ultrasound System For Prostate Tissue Ablation) made by Profound Medical Inc, cleared under FDA 510(k) K202286 on 16 Sep 2020 and listed in FDA GUDID since 26 May 2022 (UDI-DI 07540281000908), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07540281000908 | Date26 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202286 | Date16 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 07540281000908
- FDA 510(k) database K202286
Across registries
- FDA 510(k) K202286 decided 16 Sep 2020 Active
- FDA GUDID UDI-DI 07540281000908 listed 26 May 2022 Listed
Timeline
- Cleared FDA 510(k) K202286
- Listed FDA GUDID 07540281000908
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tulsa-Pro
- Generic name
- Therapeutic oncological/gynaecological ultrasound system
- Model / reference
- 106647
- Primary DI / UDI-DI
- 07540281000908
- 510(k) Number
- FDA product code
- PLP
- GMDN term
- Therapeutic oncological/gynaecological ultrasound system
- Device class
- Class II
- Regulation number
- 876.4340
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional