510(k) · Cleared
ClearedSurgisorb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samyang Corp. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jun 4, 1999 after a 179-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Jun 4, 1999
- Review
- 179 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 7 citing it directly.
- This deviceK984374 SurgisorbSamyang Corp. · 1999
- Descendant · cites it directly · 7 of its ownK031443 Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003
- Descendant · 2 generations on · 5 of its ownK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK160529 Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016
- Descendant · 3 generations on · 1 of its ownK141206 Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK222783 MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003 · cites it directly7descendants
- K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc. · 2010 · 2 generations on5descendants
- K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016 · 3 generations on1descendant
- K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015 · 3 generations on1descendant
- K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984374 | Surgisorb | Samyang Corp. | 1999 | — |
| +1 | K031443 | Lsi Solutions Suture Quick Load Products | Lsi Solutions | 2003 | — |
| +2 | K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | Lsi Solutions, Inc. | 2010 | — |
| +3 | K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016 | — |
| +3 | K141206 | Edwards Lifesciences Thruport Knotting System | Edwards Lifesciences, LLC | 2015 | — |
| +3 | K222783 | MD Mattress Suture Placement Device | Lsi Solutions, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | Dexon® II polyglycolic acid, synthetic absorbable surgical sutures with polycaprolate… Named without a submission number |
What descends from it? (14)
See all 147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031443 | Lsi Solutions Suture Quick Load Products | 2003 | 7 |
| K143584 | Pga Resorba, Pga Resoquick, Glycolon | 2015 | 0 |
| K102592 | Sutrazorb | 2011 | 0 |
| K080412 | Absorbable Synthetic Suture with Needle Attachment (Pga Braided) | 2008 | 0 |
| K053636 | Mani Needle & Suture Pack (Pga Absorbable) | 2006 | 0 |
| K041515 | Truglyde Absorbable Polyglycolic Acid Surgical Suture | 2005 | 0 |
| K043539 | Demetech Sterile Synthetic Absorbable Sutures (Pga) and Needles | 2005 | 0 |
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?
- Of its descendants, K031443 (Lsi Solutions, 2003) has gone furthest, with 7 descendants of its own.
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?
GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL 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/K984374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984374: Surgisorb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984374
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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