510(k) Report

510(k) · Cleared

Cleared

StitchKit

K211792510(k) SpecialCleared Jul 16, 202136-day reviewClass II21 CFR 878.4493

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Origami Surgical Inc . · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Jul 16, 2021 as substantially equivalent to K202950 (Origami Surgical, 2021) and 4 other predicates after a 36-day review. Its family tree reaches back 10 generations to 2002. 1 later device descends from it.

Decided
Jul 16, 2021
Review
36 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K014153 (2002). 43 ancestors in all, the oldest K885018 (1989). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2000: 1 other ancestor1999: 2 other ancestors1993: 1 other ancestor1998: 5 other ancestors2013: 1 other ancestor2009: 2 other ancestors1997: 3 other ancestors2004: 2 other ancestors2003: 1 other ancestor1996: 5 other ancestors2005: 1 other ancestor2002: 2 other ancestors1995: 2 other ancestors1992: 2 other ancestors1994: 1 other ancestor1989: 1 other ancestor2023: 1 descendant clearedK014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 2002K023922 · Coapt Systems Endotine Device, Model CFD-101-00197 · Coapt Systems, Inc. · 2002K032698 · Coapt Endotine Midface-ST 4.5 Device · Coapt Systems, Inc. · 2003K041593 · Featherlift Extended Length Aptos Thread · Surgical Specialties Corp · 2004×2: 2 generations cleared close together, K050548 (2005), K051609 (2005) K072028 · Quill Self-Retaining System (SRS) Comprised of Monoderm · Surgical Specialties Corp · 2007K100257 · VLOC9ABSORBABLE Wound Closure Device · Surgical Devices, A Division of Tyco Healthcare · 2010 · recalledK173874 · StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO · Origami Surgical, LLC · 2018K202950 · StitchKit COMBO · Origami Surgical · 20211990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors4 generations back: 7 other ancestors5 generations back: 9 other ancestors6 generations back: 2 other ancestors7 generations back: 2 other ancestors8 generations back: 2 other ancestors 1 generation forward: 1 descendant K202950 · StitchKit COMBO · Origami Surgical · 2021K173874 · StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO · Origami Surgical, LLC · 2018K100257 · VLOC9ABSORBABLE Wound Closure Device · Surgical Devices, A Division of Tyco Healthcare · 2010 · recalledK072028 · Quill Self-Retaining System (SRS) Comprised of Monoderm · Surgical Specialties Corp · 2007K051609 · Quill Synthetic Absorbable Barbed Suture · Quill Medical, Inc. · 2005K050548 · Contour Midface Opposing Uni-Directional Threads · Surgical Specialties Corp · 2005K041593 · Featherlift Extended Length Aptos Thread · Surgical Specialties Corp · 2004K032698 · Coapt Endotine Midface-ST 4.5 Device · Coapt Systems, Inc. · 2003K023922 · Coapt Systems Endotine Device, Model CFD-101-00197 · Coapt Systems, Inc. · 2002K014153 · Coapt Systmes Endotine Device · Coapt Systems, Inc. · 2002−10−50
  1. Root · 10 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
  2. 6 generations between
  3. 3 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
  4. 2 generations backK173874 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018
  5. 1 generation backK202950 StitchKit COMBOOrigami Surgical · 2021
  6. This deviceK211792 StitchKitOrigami Surgical Inc . · 2021
  7. Descendant · cites it directly · 0 of its ownK221527 StitchKitOrigami Surgical Inc . · 2023
Show all 10 generations
  1. Root · 10 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
  2. 9 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
  3. 8 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
  4. 7 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
  5. 6 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
  6. 5 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  7. 4 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
  8. 3 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
  9. 2 generations backK173874 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018
  10. 1 generation backK202950 StitchKit COMBOOrigami Surgical · 2021
  11. This deviceK211792 StitchKitOrigami Surgical Inc . · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K221527StitchKitOrigami Surgical Inc . · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K014153Coapt Systmes Endotine DeviceCoapt Systems, Inc.2002—
−9K023922Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc.2002—
−8K032698Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc.2003—
−7K041593Featherlift Extended Length Aptos ThreadSurgical Specialties Corp2004—
−6K050548Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp2005—
−5K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2005—
−4K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp2007—
−3K100257VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare20101
−2K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC2018—
−1K202950StitchKit COMBOOrigami Surgical2021—
0 (this device)K211792StitchKitOrigami Surgical Inc .2021—
+1K221527StitchKitOrigami Surgical Inc .2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199220
199310
199410
199520
199650
199730
199850
199920
200010
200220
200310
200420
200510
200920
201010
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K211792, 2002–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.7 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K202950StitchKit COMBO
Summary page 4
…8.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Devices to Which the Device is Substantially Equivalent [product code]:  K202950: StitchKit® COMBO, [GAM (Primary), GAP, GCJ and NAY]  K000037: Biosyn™ Monofilament Absorbable Sutures, [GAM];  K9909…
Origami Surgical2021—
*K000037Monofilament Biosyn Suture
Summary page 4
…ctide) Surgical Suture Devices to Which the Device is Substantially Equivalent [product code]:  K202950: StitchKit® COMBO, [GAM (Primary), GAP, GCJ and NAY]  K000037: Biosyn™ Monofilament Absorbable Sutures, [GAM];  K990951: Maxon™ Monofilament Absorbable Sutures, [GAM];  K103052: V…
United States Surgical, A Division of Tyco Healthc200028
*K990951Maxon** Sterile, Synthetic, Absorbable Suture
Summary page 4
…lly Equivalent [product code]:  K202950: StitchKit® COMBO, [GAM (Primary), GAP, GCJ and NAY]  K000037: Biosyn™ Monofilament Absorbable Sutures, [GAM];  K990951: Maxon™ Monofilament Absorbable Sutures, [GAM];  K103052: V-Loc™ PBT Non-Absorbable Wound Closure Device, [GAT];  K93…
United States Surgical, A Division of Tyco Healthc19991
*K103052V-Loc (TM) Nonabsorbable Wound Closure Device
Summary page 4
…, [GAM (Primary), GAP, GCJ and NAY]  K000037: Biosyn™ Monofilament Absorbable Sutures, [GAM];  K990951: Maxon™ Monofilament Absorbable Sutures, [GAM];  K103052: V-Loc™ PBT Non-Absorbable Wound Closure Device, [GAT];  K930591: Ti-Cron™ Braided Polyester Sutures, [GAT]. Device Descrip…
Covidien, LLC2010—
*K930591TI-Cron and Dacron Sutures
Summary page 4
…t Absorbable Sutures, [GAM];  K990951: Maxon™ Monofilament Absorbable Sutures, [GAM];  K103052: V-Loc™ PBT Non-Absorbable Wound Closure Device, [GAT];  K930591: Ti-Cron™ Braided Polyester Sutures, [GAT]. Device Description: StitchKit® is a suture delivery canister which facilitates endosc…
Davis & Geck, Inc.19936

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221527StitchKitOrigami Surgical Inc .20230

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 7 companies; a new generation was cleared every 11 months on median.
  • 15 of the 43 ancestors have a recall of any class.
  • Of its descendants, K221527 (Origami Surgical Inc ., 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

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 as stated in the FDA summary.

More from Origami Surgical Inc .

2 FDA decisions under this applicant name. See the company

  • K221527StitchKitOrigami Surgical Inc . · 2023

Recent decisions in GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K211792 · printed Nov 6, 2026

Cite this page

510(k) Report. “K211792: StitchKit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211792

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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