The following data is part of a premarket notification filed by Usgi Medical, Inc. with the FDA for Shape Locking Endoscopic Overtube.
| Device ID | K033954 |
| 510k Number | K033954 |
| Device Name: | SHAPE LOCKING ENDOSCOPIC OVERTUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | USGI MEDICAL, INC. 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Contact | Jeffrey A Anderson |
| Correspondent | Jeffrey A Anderson USGI MEDICAL, INC. 1140 CALLE CORDILLERA San Clemente, CA 92673 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-03-19 |
| Summary: | summary |