510(k) · Cleared
ClearedSofsilk Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GAP Suture, Nonabsorbable, Silk
Cleared on Mar 27, 1998 as substantially equivalent to K964581 (United States Surgical, A Division of Tyco Healthc, 1997) after a 72-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Mar 27, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964581 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964581 SofsilkUnited States Surgical, A Division of Tyco Healthc · 1997
- This deviceK980124 Sofsilk SutureUnited States Surgical, A Division of Tyco Healthc · 1998
- Descendant · cites it directly · 2 of its ownK202950 StitchKit COMBOOrigami Surgical · 2021
- Descendant · 2 generations on · 1 of its ownK211792 StitchKitOrigami Surgical Inc . · 2021
- Descendant · cites it directly · 0 of its ownK241486 Sofsilk™ Coated Braided Silk SutureCovidien · 2024
- Descendant · 3 generations on · 0 of its ownK221527 StitchKitOrigami Surgical Inc . · 2023
Most influential descendants
Showing 4 of 4 · See all- K202950StitchKit COMBOOrigami Surgical · 2021 · cites it directly2descendants
- K211792StitchKitOrigami Surgical Inc . · 2021 · 2 generations on1descendant
- K241486Sofsilk™ Coated Braided Silk SutureCovidien · 2024 · cites it directly0descendants
- K221527StitchKitOrigami Surgical Inc . · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964581 | Sofsilk | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| 0 (this device) | K980124 | Sofsilk Suture | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| +1 | K202950 | StitchKit COMBO | Origami Surgical | 2021 | — |
| +2 | K211792 | StitchKit | Origami Surgical Inc . | 2021 | — |
| +1 | K241486 | Sofsilk™ Coated Braided Silk Suture | Covidien | 2024 | — |
| +3 | K221527 | StitchKit | Origami Surgical Inc . | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 GAP? 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 GAP device
- #1 K222944 SafePath Sulturing System-Silk Suture…score 9.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K964581 | SofsilkSummary page 1…Avenue Norwalk, CT 06856 Victor M. Clavelh January 13, 1998 Natural Nonabsorbable Silk Surgical Suture Nonabsorbable Silk Suture Modified Sofsilk* Suture Sofsilk* (K964581) Modified Sofsilk * Suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced from th… | 1997 |
What descends from it? (4)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K202950 (Origami Surgical, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GAP devicesGAP Suture, Nonabsorbable, Silk: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAP
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAP
193in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAP
478in 2025
MAUDE reports naming product code GAP, 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 | 1 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 21 | 6 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 25 |
| 2016 | 2 | — | 0 | 54 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 1 | — | 1 | 340 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 0 | — | 0 | 426 |
| 2021 | 0 | — | 0 | 437 |
| 2022 | 0 | — | 0 | 419 |
| 2023 | 1 | — | 1 | 404 |
| 2024 | 3 | 193 | 0 | 455 |
| 2025 | 0 | — | 0 | 478 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Modified Sofsilk* Suture has indications for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, microsurgery and neural tissue.
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/K980124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980124: Sofsilk Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980124
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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