FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TULSA-PRO System
K Number: K211858
·
Decision Sep 6, 2022
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
12
Applicant Total
5
Review Days
447
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Basic Information
- Device Name
- TULSA-PRO System
- K Number
- K211858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4340
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Profound Medical, Inc.
- Date Received
- June 16, 2021
- Decision Date
- September 6, 2022
- Product Code
- PLP
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | FDA class 2 | Gastroenterology, Urology |
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