510(k) · Cleared
ClearedStitchKit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origami Surgical Inc . · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Feb 14, 2023 as substantially equivalent to K211792 (Origami Surgical Inc ., 2021) after a 264-day review. Its family tree reaches back 11 generations to 2002.
- Decided
- Feb 14, 2023
- Review
- 264 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K014153 (2002). 44 ancestors in all, the oldest K885018 (1989). No later device cites it as a predicate yet.
- Root · 11 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 7 generations between
- 3 generations backK173874 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018
- 2 generations backK202950 StitchKit COMBOOrigami Surgical · 2021
- 1 generation backK211792 StitchKitOrigami Surgical Inc . · 2021
- This deviceK221527 StitchKitOrigami Surgical Inc . · 2023
Show all 11 generations
- Root · 11 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 10 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 9 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 8 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 7 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 6 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 5 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- 4 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 3 generations backK173874 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018
- 2 generations backK202950 StitchKit COMBOOrigami Surgical · 2021
- 1 generation backK211792 StitchKitOrigami Surgical Inc . · 2021
- This deviceK221527 StitchKitOrigami Surgical Inc . · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −10 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −9 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −8 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −7 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −6 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −5 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| −4 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| −3 | K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC | 2018 | — |
| −2 | K202950 | StitchKit COMBO | Origami Surgical | 2021 | — |
| −1 | K211792 | StitchKit | Origami Surgical Inc . | 2021 | — |
| 0 (this device) | K221527 | StitchKit | Origami Surgical Inc . | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 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 |
|---|---|---|---|
| * | K211792 | StitchKitSummary page 4…er: 21 CFR 878.4493 Regulation Name: Absorbable Poly (Glycolide/L-Lactide) Surgical Suture Devices to Which the Device is Substantially Equivalent: • K211792: StitchKit®, product code GAM (Primary), GAT, GCJ and NAY Device Description: StitchKit® is a sterile, single-use plastic canist… | 2021 |
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 21 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 15 of the 44 ancestors have a recall of any class.
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. 2023, 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?
StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate
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/K221527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221527: StitchKit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221527
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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