The following data is part of a premarket notification filed by Medi-tate Ltd. with the FDA for Itind System.
| Device ID | K210138 |
| 510k Number | K210138 |
| Device Name: | ITind System |
| Classification | Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia |
| Applicant | Medi-Tate Ltd. 17 Hauman Street Hadera, IL 3850169 |
| Contact | Lihi Liviatan |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | QKA |
| CFR Regulation Number | 876.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-06-25 |