The following data is part of a premarket notification filed by Xenolith Medical with the FDA for Xenx Stone Management Device.
| Device ID | K123438 |
| 510k Number | K123438 |
| Device Name: | XENX STONE MANAGEMENT DEVICE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | XENOLITH MEDICAL Hahadas 9 PO Box 241 Or Akiva, IL 3065201 |
| Contact | Ofer Zigman |
| Correspondent | Ofer Zigman XENOLITH MEDICAL Hahadas 9 PO Box 241 Or Akiva, IL 3065201 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-08 |
| Decision Date | 2013-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700512975731 | K123438 | 000 |
| 03700512975724 | K123438 | 000 |
| 03700512975243 | K123438 | 000 |
| 03700512975236 | K123438 | 000 |