The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Colonic Splinting Overtube, Model 00711145.
| Device ID | K092221 |
| 510k Number | K092221 |
| Device Name: | COLONIC SPLINTING OVERTUBE, MODEL 00711145 |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Craig L Moore |
| Correspondent | Craig L Moore UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2009-10-20 |
| Summary: | summary |