510(k) K210138
K210138 is an FDA 510(k) premarket notification submitted by Medi-Tate , Ltd. for the device "iTind System". The FDA issued a decision of Substantially Equivalent on June 25, 2021. 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
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2021
- Date Received
- January 19, 2021
- Clearance Type
- Traditional
- 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.