510(k) · Cleared
ClearedWego-Stainless Steel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foosin Medical Supplies Inc., Ltd. · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Feb 19, 2020 as substantially equivalent to K170767 (ETHICON, Inc., 2017) after a 90-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 19, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K946173 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK946173 Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide…ETHICON, Inc. · 1995 · Recalled
- 1 generation backK170767 Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc. · 2017
- This deviceK193209 Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene… | ETHICON, Inc. | 1995 | 10 |
| −1 | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. | 2017 | — |
| 0 (this device) | K193209 | Wego-Stainless Steel | Foosin Medical Supplies Inc., Ltd. | 2020 | — |
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 GAQ? 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 GAQ device
- #1 K203855 CoNextions TR Tendon Repair Systemscore 3.8 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K170767 | Surgical Stainless Steel Suture, Stainless Steel SutureSummary page 5…mplies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures. 5. Identification of Predicate Device 510(k) Number: K170767 Product Name: Surgical Stainless Steel Suture 6. Non-Clinical Test Conclusion Non clinical tests were conducted t… | 2017 |
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?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 22.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K170767.
How does its category compare?
All GAQ devicesGAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GAQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GAQ
Too few GAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GAQ
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAQ
83in 2025
MAUDE reports naming product code GAQ, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 2 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 23 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 52 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 100 |
| 2024 | 0 | — | 0 | 176 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193209: Wego-Stainless Steel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193209
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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