510(k) · Cleared
ClearedStainless Steel Surgical Suture, Non-Absorbable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Mar 28, 2003 after a 53-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 28, 2003
- Review
- 53 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK030351 Stainless Steel Surgical Suture, Non-AbsorbableCp Medical · 2003
- Descendant · cites it directly · 1 of its ownK063603 Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15…Suturtek Incorporated · 2007
- Descendant · cites it directly · 0 of its ownK172146 MeristeelM/s. Meril Endo Surgery Private Limited. · 2018
- Descendant · cites it directly · 0 of its ownK143582 Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide…Resorba Medical GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009
Most influential descendants
Showing 4 of 4 · See all- K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated · 2007 · cites it directly1descendant
- K172146MeristeelM/s. Meril Endo Surgery Private Limited. · 2018 · cites it directly0descendants
- K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015 · cites it directly0descendants
- K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030351 | Stainless Steel Surgical Suture, Non-Absorbable | Cp Medical | 2003 | — |
| +1 | K063603 | Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | Suturtek Incorporated | 2007 | — |
| +1 | K172146 | Meristeel | M/s. Meril Endo Surgery Private Limited. | 2018 | — |
| +1 | K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel | Resorba Medical GmbH | 2015 | — |
| +2 | K090686 | Sic Brevetti S.R.L. Device for Sternal Synthesis | Sic Brevetti S.R.L. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 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
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by Davis-Geck Named without a submission number | |
| * | — | Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by US Surgical Named without a submission number | |
| * | — | Nonabsorbable Surgical Sutures, Monofilament Stainless Steel manufactured by Ethicon, Inc. Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K063603 (Suturtek Incorporated, 2007) has gone furthest, with 1 descendant of its own.
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.
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?
Stainless Steel Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and certain orthopedic procedures including cerclage and tendon repair.
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/K030351 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030351: Stainless Steel Surgical Suture, Non-Absorbable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030351
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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