K160654 is an FDA 510(k) clearance for the GastriSail Gastric Positioning System 40 Fr/CH (13.3mm). This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on May 4, 2016, 57 days after receiving the submission on March 8, 2016.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K160654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2016 |
| Decision Date | May 04, 2016 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |