510(k) · Cleared
ClearedPolyglytone 6211 Synthetic Absorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Sep 28, 2004 as substantially equivalent to K013671 (United States Surgical, A Division of Tyco Healthc, 2002) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1989. 11 later devices descend from it.
- Decided
- Sep 28, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K885018 (1989). 5 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK885018 Absorbable Surgical Gut Suture*United States Surgical, A Division of Tyco Healthc · 1989
- 2 generations backK013671 L-25 Absorbable Surigcal SutureUnited States Surgical, A Division of Tyco Healthc · 2002
- 1 generation backK032586 Caprosyn Absorbable SutureUnited States Surgical, A Division of Tyco Healthc · 2003
- This deviceK042141 Polyglytone 6211 Synthetic Absorbable SutureTeleflex Medical · 2004
- Descendant · cites it directly · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- Descendant · 2 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · 2 generations on · 2 of its ownK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
- Descendant · 3 generations on · 1 of its ownK242201 HyperSuture White/Green Extension LineThreadstone, LLC · 2025
- Descendant · 3 generations on · 1 of its ownK210675 EasyWhipWinter Innovations, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · cites it directly10descendants
- K230311HyperSutureThreadstone, LLC · 2023 · 2 generations on4descendants
- K191268Force Fiber SutureTeleflex Medical Incorporated · 2019 · 2 generations on2descendants
- K242201HyperSuture White/Green Extension LineThreadstone, LLC · 2025 · 3 generations on1descendant
- K210675EasyWhipWinter Innovations, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885018 | Absorbable Surgical Gut Suture* | United States Surgical, A Division of Tyco Healthc | 1989 | — |
| −2 | K013671 | L-25 Absorbable Surigcal Suture | United States Surgical, A Division of Tyco Healthc | 2002 | — |
| −1 | K032586 | Caprosyn Absorbable Suture | United States Surgical, A Division of Tyco Healthc | 2003 | — |
| 0 (this device) | K042141 | Polyglytone 6211 Synthetic Absorbable Suture | Teleflex Medical | 2004 | — |
| +1 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +2 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +2 | K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019 | — |
| +3 | K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025 | — |
| +3 | K210675 | EasyWhip | Winter Innovations, Inc. | 2021 | — |
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 |
|---|---|---|
| 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? (2)
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 SutureSummary page 2…tended use, materials, design, and performance characteristics to the currently cleared U.S. Surgical Caprosyn TM Monofilament Synthetic Absorbable Suture (K01 3671 & K032586). The determination of substantial equivalence for this device was based on a detailed device… | 2002 |
| * | K032586 | Caprosyn Absorbable SutureSummary page 2…als, design, and performance characteristics to the currently cleared U.S. Surgical Caprosyn TM Monofilament Synthetic Absorbable Suture (K01 3671 & K032586). The determination of substantial equivalence for this device was based on a detailed device description, per… | 2003 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force… | 2018 | 10 |
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 15 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K181774 (Teleflex Medical Incorporated, 2018) has gone furthest, with 10 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?
Polyglytone* 6211™ Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042141: Polyglytone 6211 Synthetic 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/K042141
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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