510(k) · Cleared
ClearedGastriSail Gastric Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Feb 25, 2015 as substantially equivalent to K071764 (Obtech Medical Sarl, 2007) and 1 other predicate after a 120-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Feb 25, 2015
- Review
- 120 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002838 (2001). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 2 generations backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- 1 generation backK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- This deviceK143088 GastriSail Gastric Positioning SystemCovidien · 2015
- Descendant · cites it directly · 0 of its ownK160654 GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| −2 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| −1 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| 0 (this device) | K143088 | GastriSail Gastric Positioning System | Covidien | 2015 | — |
| +1 | K160654 | GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) | Covidien, LLC | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K071764 | Realize Gastric Calibration Tube, Models GCT180, GCT360Summary page 4…Tubes, Gastrointestinal (and Accessories) PREDICATE DEVICES: 1). Realize™ Gastric Calibration Tube (K071764). Mfg by Ethicon… | 2007 |
| * | K130483 | Boehringer Gastric Sizing TubeSummary page 4…2). ViSiGi3D™ Sleeve Gastrectomy Calibration System with Bulb (K130483). Mfg by Boehringer Laboratories DEVICE DESCRIPTION: The GastriSail™ Gastric Positioning… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160654 | GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K160654 (Covidien, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071764.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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/K143088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143088: GastriSail Gastric Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143088
Report an extraction error
Are you the manufacturer?
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