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 |