# K143088: GastriSail Gastric Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Feb 25, 2015 after 120 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002838 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071764: Realize Gastric Calibration Tube, Models GCT180, GCT360, Obtech Medical Sarl (2007) Summary page 4.
- K130483: Boehringer Gastric Sizing Tube, Boehringer Laboratories, LLC (2013) Summary page 4.

## Most influential descendants
- K160654: GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) (2016), 0 descendants of its own

## 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/K143088
Methodology: https://510kreport.com/methodology