510(k) · Cleared
ClearedSuture Placement Device and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsi Solutions · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 13, 1998 as substantially equivalent to K954853 (United States Surgical, A Division of Tyco Healthc, 1995) after a 75-day review. Its family tree reaches back 1 generation to 1995. 16 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954853 (1995). 16 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK954853 Auto Suture Suture ClosureUnited States Surgical, A Division of Tyco Healthc · 1995
- This deviceK981531 Suture Placement Device and AccessoriesLsi Solutions · 1998
- Descendant · cites it directly · 6 of its ownK123811 StitchkitOrigami Surgical, LLC · 2013
- Descendant · cites it directly · 6 of its ownK040232 Lsi Sew-Right R Series Suture Placement Device and Access Product…Lsi Solutions · 2004
- Descendant · cites it directly · 5 of its ownK100593 Suture Placement Device and Accessories, Flexible Suture Placement…Lsi Solutions, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK173874 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018
- Descendant · 3 generations on · 2 of its ownK202950 StitchKit COMBOOrigami Surgical · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123811StitchkitOrigami Surgical, LLC · 2013 · cites it directly6descendants
- K040232Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model…Lsi Solutions · 2004 · cites it directly6descendants
- K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc. · 2010 · cites it directly5descendants
- K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018 · 2 generations on3descendants
- K202950StitchKit COMBOOrigami Surgical · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954853 | Auto Suture Suture Closure | United States Surgical, A Division of Tyco Healthc | 1995 | — |
| 0 (this device) | K981531 | Suture Placement Device and Accessories | Lsi Solutions | 1998 | — |
| +1 | K123811 | Stitchkit | Origami Surgical, LLC | 2013 | — |
| +1 | K040232 | Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right… | Lsi Solutions | 2004 | — |
| +1 | K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | Lsi Solutions, Inc. | 2010 | — |
| +2 | K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC | 2018 | — |
| +3 | K202950 | StitchKit COMBO | Origami Surgical | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K954853 | Auto Suture Suture ClosureSummary page 1…rgical Instrument for General Use (per 21 CFR, §878.4800) and an accessory to an endoscope (per 21 CFR §876.1500). AUTO SUTURE* Suture Closure** device and accessories (K954853) The LSI Suture Placement device and accessories intended for the approximation of surgical wounds by passing ligature through s… | 1995 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123811 | Stitchkit | 2013 | 6 |
| K040232 | Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model… | 2004 | 6 |
| K100593 | Suture Placement Device and Accessories, Flexible Suture Placement Device and… | 2010 | 5 |
| K202551 | Cor-Knot Micro | 2021 | 0 |
| K063462 | Neatstitch Neatclose Suturing Device | 2007 | 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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The LSI Suture Placement device and accessories are intended for use in the approximation of soft 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/K981531 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981531: Suture Placement Device and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981531
Report an extraction error
Are you the manufacturer?
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