510(k) K160654 ยท KNT Tubes, Gastrointestinal (And Accessories)
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
| Applicant | Covidien, LLC, North Haven CT, US |
| Decision | Substantially Equivalent, May 4, 2016 |
| Received | Mar 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160654
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2017 | Covidien LLC GastriSail" Gastric Positioning Device
Product Usage:
The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decom Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.