The following data is part of a premarket notification filed by Crospon, Ltd. with the FDA for Endoflip Ecd.
| Device ID | K110531 |
| 510k Number | K110531 |
| Device Name: | ENDOFLIP ECD |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | CROSPON, LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden CROSPON, LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-24 |
| Decision Date | 2011-10-06 |
| Summary: | summary |