The following data is part of a premarket notification filed by Covidien with the FDA for Gastrisail Gastric Positioning System.
| Device ID | K143088 |
| 510k Number | K143088 |
| Device Name: | GastriSail Gastric Positioning System |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-28 |
| Decision Date | 2015-02-25 |
| Summary: | summary |