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 K100461 (Riverpoint Medical, 2010) after a 302-day review. Its family tree reaches back 4 generations to 1996. 2 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 4 generations to K960653 (1996). 10 ancestors in all, the oldest K900198 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK960653 Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. · 1996 · Recalled
- 3 generations backK050845 Monocryl Plus Antibacterial SutureETHICON, Inc. · 2005 · Recalled
- 2 generations backK061037 PDS Plus Antibacterial SutureETHICON, Inc. · 2006 · Recalled
- 1 generation backK100461 PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · Recalled
- This deviceK130737 Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK142810 WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK173779 Rexmono, PdrexSm Eng Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960653 | Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) | ETHICON, Inc. | 1996 | 2 |
| −3 | K050845 | Monocryl Plus Antibacterial Suture | ETHICON, Inc. | 2005 | 1 |
| −2 | K061037 | PDS Plus Antibacterial Suture | ETHICON, Inc. | 2006 | 9 |
| −1 | K100461 | PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut | Riverpoint Medical | 2010 | 1 |
| 0 (this device) | K130737 | Synthetic Absorbable Suture | Foosin Medical Supplies Inc., Ltd. | 2014 | — |
| +1 | K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | Foosin Medical Supplies Inc., Ltd. | 2014 | — |
| +2 | K173779 | Rexmono, Pdrex | Sm Eng Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K100461 | PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutSummary page 2…soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures. 5. Predicate Device Identification 5 10(k) Number: K 100461 Product Name: MoNo Q (PGCL) Manufacturer: Riverpoint Medical 6. Device Description The WEGO-PGCL Absorbable… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142810 | WEGO-PGCL Absorbable Surgical Monofilament Suture | 2014 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K142810 (Foosin Medical Supplies Inc., Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K100461.
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-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/ar ligation, but not for use in cardiovascular or neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130737 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130737: 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/K130737
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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