510(k) · Cleared
ClearedSofsilk
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 Jan 16, 1997 after a 62-day review. The summary cites 3 numbers, none of which could be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Jan 16, 1997
- Review
- 62 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 3
5 later devices descend from it, 1 citing it directly.
- This deviceK964581 SofsilkUnited States Surgical, A Division of Tyco Healthc · 1997
- Descendant · cites it directly · 4 of its ownK980124 Sofsilk SutureUnited States Surgical, A Division of Tyco Healthc · 1998
- Descendant · 2 generations on · 2 of its ownK202950 StitchKit COMBOOrigami Surgical · 2021
- Descendant · 3 generations on · 1 of its ownK211792 StitchKitOrigami Surgical Inc . · 2021
- Descendant · 2 generations on · 0 of its ownK241486 Sofsilk™ Coated Braided Silk SutureCovidien · 2024
- Descendant · 4 generations on · 0 of its ownK221527 StitchKitOrigami Surgical Inc . · 2023
Most influential descendants
Showing 5 of 5 · See all- K980124Sofsilk SutureUnited States Surgical, A Division of Tyco Healthc · 1998 · cites it directly4descendants
- K202950StitchKit COMBOOrigami Surgical · 2021 · 2 generations on2descendants
- K211792StitchKitOrigami Surgical Inc . · 2021 · 3 generations on1descendant
- K241486Sofsilk™ Coated Braided Silk SutureCovidien · 2024 · 2 generations on0descendants
- K221527StitchKitOrigami Surgical Inc . · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964581 | Sofsilk | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| +1 | K980124 | Sofsilk Suture | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| +2 | K202950 | StitchKit COMBO | Origami Surgical | 2021 | — |
| +3 | K211792 | StitchKit | Origami Surgical Inc . | 2021 | — |
| +2 | K241486 | Sofsilk™ Coated Braided Silk Suture | Covidien | 2024 | — |
| +4 | K221527 | StitchKit | Origami Surgical Inc . | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K900840 | Sofsilk* Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…k Surgical Suture COMMON NAME: PROPRIETARY NAME: PREDICATE DEVICE: DEVICE DESCRIPTION: INTENDED USE: MATERIALS: Nonabsorbable Silk Suture SOFSILK* / . A SOFSILK* (K900840, K902874 and K903509) SOFSILK* suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produ… | |
| Kept off the family tree | K902874 | Sofsilk* Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…l Suture COMMON NAME: PROPRIETARY NAME: PREDICATE DEVICE: DEVICE DESCRIPTION: INTENDED USE: MATERIALS: Nonabsorbable Silk Suture SOFSILK* / . A SOFSILK* (K900840, K902874 and K903509) SOFSILK* suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced by th… | |
| Kept off the family tree | K903509 | Sofsilk* Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…MMON NAME: PROPRIETARY NAME: PREDICATE DEVICE: DEVICE DESCRIPTION: INTENDED USE: MATERIALS: Nonabsorbable Silk Suture SOFSILK* / . A SOFSILK* (K900840, K902874 and K903509) SOFSILK* suture is a nonabsorbable, sterile, flexible multifilament thread, prepared from silk fiber produced by the species Bo… |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980124 | Sofsilk Suture | 1998 | 4 |
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, K980124 (United States Surgical, A Division of Tyco Healthc, 1998) has gone furthest, with 4 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?
Due to its nonabsorbable nature, SOF SILK* suture is intended for the approximation of tissues where prolonged retention of tensile strength is required.
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/K964581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964581: Sofsilk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964581
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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