De Novo · Granted
GrantedProdiGI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · QSW Endoscopic Traction Device
Granted on Jun 13, 2022 as a new device type through De Novo after a 150-day review. 1 later device descends from it.
- Decided
- Jun 13, 2022
- Review
- 150 days
- Class
- Class II
- Product code
- QSW
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN220006 ProdiGICovidien, LLC · 2022
- Descendant · cites it directly · 0 of its ownK222354 Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K222354Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220006 | ProdiGI | Covidien, LLC | 2022 | — |
| +1 | K222354 | Elastic Traction System | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA De Novo 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 QSW? 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 QSW device
- #1 K222354 Elastic Traction Systemscore 4.1 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K222354 | Elastic Traction System | 2022 | 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?
- Of its descendants, K222354 (Micro-Tech (Nanjing) Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QSW devicesQSW Endoscopic Traction Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QSW
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QSW
Too few QSW 510(k)s in any year since 2007 to give a median.
Recalls per year · QSW
No recall names QSW since 2007.
Adverse event reports per year · QSW
2in 2025
MAUDE reports naming product code QSW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220006 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220006: ProdiGI.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220006
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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