The following data is part of a premarket notification filed by Xenolith Medical with the FDA for Xenx.
| Device ID | K113692 |
| 510k Number | K113692 |
| Device Name: | XENX |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | XENOLITH MEDICAL 1 LESHEM, P.O. BOX 720 Kityat-gat, IL 82000 |
| Contact | Ofer Zigman |
| Correspondent | Ofer Zigman XENOLITH MEDICAL 1 LESHEM, P.O. BOX 720 Kityat-gat, IL 82000 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-15 |
| Decision Date | 2012-08-09 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() XENX 90107574 not registered Live/Pending |
XENX TECHNOLOGY LIMITED 2020-08-11 |
![]() XENX 85407570 4131882 Dead/Cancelled |
Xenolith Medical, Ltd 2011-08-25 |