510(k) · Cleared
ClearedDexon II Absorbable Surgical Suture, U.S.P.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Cyanamid Co. · GAN Suture, Absorbable, Synthetic
Cleared on Jul 5, 1990 after a 170-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.
- Decided
- Jul 5, 1990
- Review
- 170 days
- Class
- Class II
- Product code
- GAN
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 3 citing it directly.
- This deviceK900198 Dexon II Absorbable Surgical Suture, U.S.P.American Cyanamid Co. · 1990
- Descendant · cites it directly · 27 of its ownK972566 Dexon VioletDavis & Geck, Inc. · 1997
- Descendant · cites it directly · 14 of its ownK992088 Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · Recalled
- Descendant · 2 generations on · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- Descendant · 2 generations on · 5 of its ownK100461 PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · Recalled
- Descendant · 3 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K972566Dexon VioletDavis & Geck, Inc. · 1997 · cites it directly27descendants
- K992088Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) · 1999 · cites it directly14descendants
- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · 2 generations on10descendants
- K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · 2 generations on5descendants
- K230311HyperSutureThreadstone, LLC · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900198 | Dexon II Absorbable Surgical Suture, U.S.P. | American Cyanamid Co. | 1990 | — |
| +1 | K972566 | Dexon Violet | Davis & Geck, Inc. | 1997 | — |
| +1 | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | 1999 | 6 |
| +2 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +2 | K100461 | PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut | Riverpoint Medical | 2010 | 1 |
| +3 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
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 GAN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (28)
See all 283 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, K972566 (Davis & Geck, Inc., 1997) has gone furthest, with 27 descendants of its own.
How does its category compare?
All GAN devicesGAN Suture, Absorbable, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAN
FDA has decided no GAN device since 2007.
Median 510(k) review, days · GAN
Too few GAN 510(k)s in any year since 2007 to give a median.
Recalls per year · GAN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAN
410in 2025
MAUDE reports naming product code GAN, 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 | 0 | — | 0 | 86 |
| 2008 | 0 | — | 0 | 124 |
| 2009 | 0 | — | 0 | 67 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 0 | — | 0 | 62 |
| 2012 | 0 | — | 0 | 157 |
| 2013 | 0 | — | 0 | 103 |
| 2014 | 0 | — | 0 | 92 |
| 2015 | 0 | — | 0 | 76 |
| 2016 | 0 | — | 0 | 63 |
| 2017 | 0 | — | 0 | 67 |
| 2018 | 0 | — | 0 | 400 |
| 2019 | 0 | — | 0 | 434 |
| 2020 | 0 | — | 0 | 278 |
| 2021 | 0 | — | 0 | 301 |
| 2022 | 0 | — | 0 | 327 |
| 2023 | 0 | — | 0 | 343 |
| 2024 | 0 | — | 1 | 450 |
| 2025 | 0 | — | 0 | 410 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900198 · printed Nov 4, 2026
Cite this page
510(k) Report. “K900198: Dexon II Absorbable Surgical Suture, U.S.P..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K900198
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026