510(k) · Cleared
ClearedSuture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsi Solutions, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Oct 13, 2010 as substantially equivalent to K981531 (Lsi Solutions, 1998) and 4 other predicates after a 225-day review. Its family tree reaches back 4 generations to 1993. 5 later devices descend from it.
- Decided
- Oct 13, 2010
- Review
- 225 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K933887 (1993). 14 ancestors in all, the oldest K771412 (1977). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 3 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 2 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 1 generation backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- This deviceK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK160529 Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016
- Descendant · cites it directly · 1 of its ownK141206 Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015
- Descendant · cites it directly · 0 of its ownK222783 MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD…Lsi Solutions · 2020
- Descendant · 2 generations on · 0 of its ownK150882 Edwards Suture Fastening SystemEdwards Lifesciences, LLC · 2015 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions · 2016 · cites it directly1descendant
- K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC · 2015 · cites it directly1descendant
- K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024 · cites it directly0descendants
- K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions · 2020 · 2 generations on0descendants
- K150882Edwards Suture Fastening SystemEdwards Lifesciences, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −3 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −2 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −1 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| 0 (this device) | K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | Lsi Solutions, Inc. | 2010 | — |
| +1 | K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016 | — |
| +1 | K141206 | Edwards Lifesciences Thruport Knotting System | Edwards Lifesciences, LLC | 2015 | — |
| +1 | K222783 | MD Mattress Suture Placement Device | Lsi Solutions, Inc. | 2024 | — |
| +2 | K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | Lsi Solutions | 2020 | — |
| +2 | K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K981531 | Suture Placement Device and AccessoriesSummary page 1…Non-absorbable Surgical Sutures 21CFR Part 878.5010 Predicate LSI Suture Placement Device and Accessories (K98 153 1) Devices: LSI Flexible Suture Placement Device and Accessories (KOl11016)… | 1998 |
| * | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories Product | 2001 |
| * | K040232 | Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model…Summary page 1…LSI Flexible Suture Placement Device and Accessories (KOl11016) LSI "R" Series Placement Device and Accessories (K040232) LSI Suture Quick Load® Products (K03 1443)… | 2004 |
| * | K031443 | Lsi Solutions Suture Quick Load ProductsSummary page 1…LSI "R" Series Placement Device and Accessories (K040232) LSI Suture Quick Load® Products (K03 1443) Coalescent Surgical U-Clip® (KO 12317) Description:… | 2003 |
| * | K012317 | Coalescent Surgical U-Clip | 2001 |
What descends from it? (5)
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 17 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K160529 (Lsi Soultions, 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K981531.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
Approximation of soft tissue and prosthetic materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100593 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100593
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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