The following data is part of a premarket notification filed by Usgi Medical, Inc. with the FDA for Shape-lockable Endoscopic Overtube.
| Device ID | K023902 |
| 510k Number | K023902 |
| Device Name: | SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | USGI MEDICAL, INC. 2 DELPHINUS Irvine, CA 92612 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon USGI MEDICAL, INC. 2 DELPHINUS Irvine, CA 92612 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-22 |
| Decision Date | 2003-08-20 |
| Summary: | summary |