K210138 is an FDA 510(k) clearance for the iTind System. This device is classified as a Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia (Class II - Special Controls, product code QKA).
Submitted by Medi-Tate , Ltd. (Hadera, IL). The FDA issued a Cleared decision on June 25, 2021, 157 days after receiving the submission on January 19, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5510. 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..
| 510(k) Number | K210138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2021 |
| Decision Date | June 25, 2021 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QKA - Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5510 |
| Definition | 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. |