The following data is part of a premarket notification filed by Medi-globe Corporation with the FDA for Easypass Guidewire.
| Device ID | K153264 |
| 510k Number | K153264 |
| Device Name: | EasyPass Guidewire |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | MEDI-GLOBE CORPORATION 7850 SOUTH HARDY DRIVE STE. 112 Tempe, AZ 85284 |
| Contact | Scott Karler |
| Correspondent | Scott Karler MEDI-GLOBE CORPORATION 7850 SOUTH HARDY DRIVE STE. 112 Tempe, AZ 85284 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-05-19 |
| Summary: | summary |