The following data is part of a premarket notification filed by Endo-therapeutics, Inc. with the FDA for Endo-glide Guidewire.
| Device ID | K023603 |
| 510k Number | K023603 |
| Device Name: | ENDO-GLIDE GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | ENDO-THERAPEUTICS, INC. 1183 CEDAR ST. Safety Harbor, FL 34695 -2908 |
| Contact | Todd Adkisson |
| Correspondent | Todd Adkisson ENDO-THERAPEUTICS, INC. 1183 CEDAR ST. Safety Harbor, FL 34695 -2908 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-28 |
| Decision Date | 2003-02-19 |
| Summary: | summary |