510(k) DEN190020
DEN190020 is an FDA 510(k) premarket notification submitted by Medi-Tate , Ltd. for the device "iTind System". The FDA issued a decision of De Novo Granted on February 25, 2020. The device falls under product code QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia), a Class II device regulated under 21 CFR 876.5510. Medi-Tate , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 25, 2020
- Date Received
- April 2, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
- Device Class
- Class II
- Regulation Number
- 876.5510
- Review Panel
- GU
- Submission Type
A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.