510(k) · Cleared
ClearedSynthetic Absorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foosin Medical Supplies Inc., Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jan 14, 2014 as substantially equivalent to K122734 (Aesculap, Inc., 2012) after a 302-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Jan 14, 2014
- Review
- 302 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980704 (1998). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK980704 Safil Synthetic Absorbable Surgical SutureAesculap, Inc. · 1998
- 1 generation backK122734 Aesculap Novosyn Absorbable SutureAesculap, Inc. · 2012
- This deviceK130735 Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK180027 ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC · 2018
- Descendant · cites it directly · 0 of its ownK173043 Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK161629 CrylrexSm Eng Co., Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980704 | Safil Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 1998 | — |
| −1 | K122734 | Aesculap Novosyn Absorbable Suture | Aesculap, Inc. | 2012 | — |
| 0 (this device) | K130735 | Synthetic Absorbable Suture | Foosin Medical Supplies Inc., Ltd. | 2014 | — |
| +1 | K180027 | ACCUSYTE 3D Fiducial Marker | Radiation Products, LLC | 2018 | — |
| +1 | K173043 | Holycon Synthetic Absorbable Sutures | Nantong Holycon Medical Devices Co., Ltd. | 2017 | — |
| +1 | K161629 | Crylrex | Sm Eng Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K122734 | Aesculap Novosyn Absorbable SutureSummary page 2…and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. 5. Predicate Device Identification 510(k) Number: K 122734 Product Name: Aesculapo Novosyn Absorbable Suture Manufacturer: Aesculape Inc. 6. Device Description The WEGO-PGLA… | 2012 |
What descends from it? (3)
3 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 14.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K180027 (Radiation Products, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122734.
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. 2014, this device’s year, is highlighted.
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?
The WEGO-POLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130735: Synthetic Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130735
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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