510(k) · Cleared
ClearedRexsin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sm Eng Co., Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jul 7, 2020 as substantially equivalent to K073614 (Foosin Medical Supplies, Inc., 2008) after a 140-day review. Its family tree reaches back 8 generations to 2002.
- Decided
- Jul 7, 2020
- Review
- 140 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K014153 (2002). 22 ancestors in all, the oldest K915489 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 7 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 6 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 5 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 4 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 3 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 2 generations backK053380 Contour Thread Synthetic Absorbable Pdo Barbed SutureSurgical Specialties Corp · 2006
- 1 generation backK073614 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- This deviceK200392 RexsinSm Eng Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −7 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −6 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −5 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −4 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −3 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −2 | K053380 | Contour Thread Synthetic Absorbable Pdo Barbed Suture | Surgical Specialties Corp | 2006 | — |
| −1 | K073614 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| 0 (this device) | K200392 | Rexsin | Sm Eng Co., Ltd. | 2020 | — |
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 |
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 |
|---|---|---|---|
| * | K073614 | WG-Surgical Sutures with NeedleSummary page 4…e approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue Predicate devices 510(k) Number: K073614 Device Name: WG-Surgical Sutures with Needle Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD Device Description… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 10 months on median.
- 6 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K073614.
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. 2020, 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?
REXSIN 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200392 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200392: Rexsin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200392
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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