510(k) · Cleared
ClearedStitchKit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origami Surgical, LLC · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Dec 16, 2014 as substantially equivalent to K123811 (Origami Surgical, LLC, 2013) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 16, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954853 (1995). 5 ancestors in all, the oldest K946173 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK954853 Auto Suture Suture ClosureUnited States Surgical, A Division of Tyco Healthc · 1995
- 2 generations backK981531 Suture Placement Device and AccessoriesLsi Solutions · 1998
- 1 generation backK123811 StitchkitOrigami Surgical, LLC · 2013
- This deviceK142639 StitchKitOrigami Surgical, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954853 | Auto Suture Suture Closure | United States Surgical, A Division of Tyco Healthc | 1995 | — |
| −2 | K981531 | Suture Placement Device and Accessories | Lsi Solutions | 1998 | — |
| −1 | K123811 | Stitchkit | Origami Surgical, LLC | 2013 | — |
| 0 (this device) | K142639 | StitchKit | Origami Surgical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K123811 | StitchkitSummary page 4…polypropylene surgical suture Product Code: GAW Nonabsorbable polypropylene surgical suture. Legally Marketed Devices to Which the Device is Substantially Equivalent: K123811: StitchKit® Suture Delivery Canister with ePTFE Surgical Suture K133356: Prolene® Polypropylene Surgical Suture… | 2013 |
| * | K133356 | Prolene Polypropylene Nonabsorbable SutureSummary page 4…ene surgical suture. Legally Marketed Devices to Which the Device is Substantially Equivalent: K123811: StitchKit® Suture Delivery Canister with ePTFE Surgical Suture K133356: Prolene® Polypropylene Surgical Suture K14263… | 2013 |
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 19 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K123811.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142639: StitchKit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142639
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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