# K160654: GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: May 4, 2016 after 57 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002838 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143088: GastriSail Gastric Positioning System, Covidien (2015) Summary page 4.

## Recalls of this device
- Sep 21, 2017 · Class II · Z-0640-2018: Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.

## Indications for use
The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.

Source page: https://510kreport.com/device/K160654
Methodology: https://510kreport.com/methodology