510(k) · Cleared
ClearedElastic Traction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · QSW Endoscopic Traction Device
Cleared on Oct 3, 2022 as substantially equivalent to DEN220006 (Covidien, LLC, 2022) after a 60-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Oct 3, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- QSW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220006 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220006 ProdiGICovidien, LLC · 2022
- This deviceK222354 Elastic Traction SystemMicro-Tech (Nanjing) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220006 | ProdiGI | Covidien, LLC | 2022 | — |
| 0 (this device) | K222354 | Elastic Traction System | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
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 QSW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN220006 | ProdiGISummary page 5…Page 2 of 6 4. Identification of Predicate Device De Novo Number: DEN220006 Product Name: ProdiGI Traction Wire Manufacturer: Covidien LLC. 5. Indications for Use The Elastic Tra… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon.
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/K222354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222354: Elastic Traction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222354
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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