EndoFLIP
System, Gastrointestinal Motility (electrical)
CROSPON LTD.
The following data is part of a premarket notification filed by Crospon Ltd. with the FDA for Endoflip.
Pre-market Notification Details
| Device ID | K160725 |
| 510k Number | K160725 |
| Device Name: | EndoFLIP |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | CROSPON LTD. GALWAY BUSINESS PARK, DANGAN Galway, IE |
| Contact | John O'dea |
| Correspondent | Paul Dryden CROSPON LTD. GALWAY BUSINESS PARK, DANGAN Galway, IE |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-16 |
| Decision Date | 2016-05-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530810166 | K160725 | 000 |
| 05391530810050 | K160725 | 000 |
| 05391530810005 | K160725 | 000 |
Trademark Results [EndoFLIP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOFLIP 77172827 4116590 Live/Registered |
FLIP TECHNOLOGIES LIMITED 2007-05-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.