The following data is part of a premarket notification filed by Covidien Llc with the FDA for Gastrisail Gastric Positioning System 40 Fr/ch (13.3mm).
| Device ID | K160654 |
| 510k Number | K160654 |
| Device Name: | GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Covidien LLC 60 MIDDLETOWN AVE North Haven, CT 06473 |
| Contact | Rebecca Magnanimo |
| Correspondent | Rebecca Magnanimo Covidien LLC 60 MIDDLETOWN AVE North Haven, CT 06473 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-08 |
| Decision Date | 2016-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521517384 | K160654 | 000 |