510(k) · Cleared
Recalled · Class II · 2024Sofsilk 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 May 11, 1998 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 13 times.
- Decided
- May 11, 1998
- Review
- 42 days
- Class
- Class II
- Product code
- GAP
- Recalls
- 13
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2024 | Class II | Z-1697-2024 | Process control | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence… |
| Dec 21, 2023 | Class II | Z-0845-2024 | Process control | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and… |
| Dec 2, 2022 | Class II | Z-1176-2023 | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| Jun 3, 2011 | Not classified | Z-2812-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2818-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2817-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2810-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2811-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2814-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2816-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2815-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2813-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2819-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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 | — |
https://510kreport.com/device/K981128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981128: 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/K981128
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026