The following data is part of a premarket notification filed by Usgi Medical with the FDA for Usgi Transport Endoscopic Guide.
| Device ID | K061216 |
| 510k Number | K061216 |
| Device Name: | USGI TRANSPORT ENDOSCOPIC GUIDE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | USGI MEDICAL 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Contact | Mary Lou Mooney |
| Correspondent | Mary Lou Mooney USGI MEDICAL 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-02 |
| Decision Date | 2006-05-15 |