510(k) · Cleared
ClearedCaprosyn Absorbable 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 · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Nov 17, 2003 as substantially equivalent to K013671 (United States Surgical, A Division of Tyco Healthc, 2002) after an 87-day review. Its family tree reaches back 2 generations to 1989. 12 later devices descend from it.
- Decided
- Nov 17, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K885018 (1989). 4 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK885018 Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc · 1989
- 1 generation backK013671 L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002
- This deviceK032586 Caprosyn Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 2003
- Descendant · cites it directly · 11 of its ownK042141 Polyglytone 6211 Synthetic Absorbable SutureTeleflex Medical · 2004
- 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 · 3 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · 3 generations on · 2 of its ownK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
- Descendant · 4 generations on · 1 of its ownK242201 HyperSuture White/Green Extension LineThreadstone, LLC · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K042141Polyglytone 6211 Synthetic Absorbable SutureTeleflex Medical · 2004 · cites it directly11descendants
- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · 2 generations on10descendants
- K230311HyperSutureThreadstone, LLC · 2023 · 3 generations on4descendants
- K191268Force Fiber SutureTeleflex Medical Incorporated · 2019 · 3 generations on2descendants
- K242201HyperSuture White/Green Extension LineThreadstone, LLC · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K885018 | Absorbable Surgical Gut Suture* | United States Surgical, A Division of Tyco Healthc | 1989 | — |
| −1 | K013671 | L-25 Absorbable Surigcal Suture | United States Surgical, A Division of Tyco Healthc | 2002 | — |
| 0 (this device) | K032586 | Caprosyn Absorbable Suture | United States Surgical, A Division of Tyco Healthc | 2003 | — |
| +1 | K042141 | Polyglytone 6211 Synthetic Absorbable Suture | Teleflex Medical | 2004 | — |
| +2 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +3 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +3 | K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019 | — |
| +4 | K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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 |
|---|---|---|---|
| * | K013671 | L-25 Absorbable Surigcal Suture | 2002 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042141 | Polyglytone 6211 Synthetic Absorbable Suture | 2004 | 11 |
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?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 12.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K042141 (Teleflex Medical, 2004) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K013671.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
Caprosyn* synthetic absorbable sutures are indicated for use in general soft tissue approximation andor ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological surgery, or microsurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032586: Caprosyn Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032586
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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