The following data is part of a premarket notification filed by Visionsense Ltd. with the FDA for Trans-anal Introducer.
| Device ID | K171208 |
| 510k Number | K171208 |
| Device Name: | Trans-anal Introducer |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Visionsense Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz, IL 49348 |
| Contact | Alex Chanin |
| Correspondent | Raymond Kelly Visionsense Ltd. 68 Southwoods Terrace Southbury, CT 06488 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-25 |
| Decision Date | 2018-02-05 |