The following data is part of a De Novo classification by Medi-tate Ltd. with the FDA for I-tind System.
| DeNovo ID | DEN190020 |
| Device Name: | I-TIND System |
| Classification | Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
| Applicant | Medi-Tate Ltd. 14 Hailan Street Or Akiva, IL 3060000 |
| Contact | Lihi Liviatan |
| Product Code | QKA |
| CFR Regulation Number | 876.5510 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2019-04-02 |
| Decision Date | 2020-02-25 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290015518083 | DEN190020 | 000 |
| 07290015518109 | DEN190020 | 000 |
| 07290015518086 | DEN190020 | 000 |
| 07290015518079 | DEN190020 | 000 |
| 07290015518062 | DEN190020 | 000 |
| 07290015518192 | DEN190020 | 000 |