510(k) · Cleared
ClearedWG-Surgical Sutures with Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foosin Medical Supplies, Inc. · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Apr 30, 2008 as substantially equivalent to K063536 (Tyco Healthcare Group, 2007) and 1 other predicate after a 126-day review. Its family tree reaches back 7 generations to 2002. 2 later devices descend from it.
- Decided
- Apr 30, 2008
- Review
- 126 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K014153 (2002). 21 ancestors in all, the oldest K915489 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 6 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 5 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 4 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 3 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 2 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 1 generation backK053380 Contour Thread Synthetic Absorbable Pdo Barbed SutureSurgical Specialties Corp · 2006
- This deviceK073614 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK200392 RexsinSm Eng Co., Ltd. · 2020
- Descendant · cites it directly · 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 |
|---|---|---|---|---|---|
| −7 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −6 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −5 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −4 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −3 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −2 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −1 | K053380 | Contour Thread Synthetic Absorbable Pdo Barbed Suture | Surgical Specialties Corp | 2006 | — |
| 0 (this device) | K073614 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +1 | K200392 | Rexsin | Sm Eng Co., Ltd. | 2020 | — |
| +1 | K173779 | Rexmono, Pdrex | Sm Eng Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 NEW? 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 NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 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 |
|---|---|---|---|
| * | K063536 | Polysorb* Synthetic Absorbable Suture with Modified PackagingSummary page 2…general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues. 1.2Predicate Device K-number: K063536 1.3Device Description The applicant devices of absorbable polyglycolic acid suture with needle consist of a polyglycolic… | 2007 |
| * | K053380 | Contour Thread Synthetic Absorbable Pdo Barbed SutureSummary page 2…h is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue. 2.2Predicate Device K-number: K053380 Shanghai Mid-Link Business Consulting Co., Ltd 2 Pr… | 2006 |
What descends from it? (2)
2 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 6 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K200392 (Sm Eng Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, 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 | 2 | — | 0 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.
Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073614: WG-Surgical Sutures with Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073614
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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