510(k) · Cleared
ClearedSilk Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davis & Geck, Inc. · GAP Suture, Nonabsorbable, Silk
Cleared on Apr 30, 1999 as substantially equivalent to K930590 (Davis & Geck, Inc., 1993) after a 260-day review. Its family tree reaches back 1 generation to 1993. 16 later devices descend from it.
- Decided
- Apr 30, 1999
- Review
- 260 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930590 (1993). 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930590 Silk SuturesDavis & Geck, Inc. · 1993
- This deviceK982853 Silk SutureDavis & Geck, Inc. · 1999
- Descendant · cites it directly · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK153307 HS SutureTapeRiverpoint Medical · 2016
- Descendant · 2 generations on · 6 of its ownK190817 HS FiberRiverpoint Medical · 2019
- Descendant · 3 generations on · 3 of its ownK231163 HS Fiber SuturesRiverpoint Medical · 2024
- Descendant · 4 generations on · 0 of its ownK253910 Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · cites it directly15descendants
- K153307HS SutureTapeRiverpoint Medical · 2016 · 2 generations on7descendants
- K190817HS FiberRiverpoint Medical · 2019 · 2 generations on6descendants
- K231163HS Fiber SuturesRiverpoint Medical · 2024 · 3 generations on3descendants
- K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930590 | Silk Sutures | Davis & Geck, Inc. | 1993 | — |
| 0 (this device) | K982853 | Silk Suture | Davis & Geck, Inc. | 1999 | — |
| +1 | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)… | Riverpoint Medical | 2010 | 2 |
| +2 | K153307 | HS SutureTape | Riverpoint Medical | 2016 | — |
| +2 | K190817 | HS Fiber | Riverpoint Medical | 2019 | — |
| +3 | K231163 | HS Fiber Sutures | Riverpoint Medical | 2024 | — |
| +4 | K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K930590 | Silk SuturesSummary page 2…he proposed Silk Surgical Suture (w/adhesive) to be substantially equivalent in design, composition and intended use, to the currently marketed Silk Suture covered under K930590. LUV s s, < ,./@ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service LLEY] P "n.’b ¢/ Food and Drug A… | 1993 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon… | 2010 | 15 |
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?
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?
Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, 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/K982853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982853: Silk Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982853
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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