510(k) · Cleared
Recalled · Class II · 2017GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 4, 2016 as substantially equivalent to K143088 (Covidien, 2015) after a 57-day review. Its family tree reaches back 4 generations to 2001. It has been recalled once.
- Decided
- May 4, 2016
- Review
- 57 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002838 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 3 generations backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- 2 generations backK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- 1 generation backK143088 GastriSail Gastric Positioning SystemCovidien · 2015
- This deviceK160654 GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| −3 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| −2 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| −1 | K143088 | GastriSail Gastric Positioning System | Covidien | 2015 | — |
| 0 (this device) | K160654 | GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) | Covidien, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143088 | GastriSail Gastric Positioning SystemSummary page 4…Gastric Positioning System CLASSIFICATION NAME: Tubes, Gastrointestinal (and Accessories) PREDICATE DEVICES: GastriSail™ Gastric Positioning System (K143088) DEVICE DESCRIPTION: The GastriSail™ Gastric Positioning System is a 40FR flexible, non-sterile,… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2017 | Class II | Z-0640-2018 | Under Investigation by firm | Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160654: GastriSail Gastric Positioning System 40 Fr/CH (13.3mm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160654
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026