510(k) · Cleared
ClearedEthicon Endosuture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 25, 1996 after a 63-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Oct 25, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK963329 Ethicon Endosuture SystemETHICON, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK060721 Lariat Loop ApplicatorSentreheart · 2006
- Descendant · cites it directly · 2 of its ownK090385 Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK142241 LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK153096 LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK102931 G-Cinch Suture GrasperUsgi Medical · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K060721Lariat Loop ApplicatorSentreheart · 2006 · cites it directly4descendants
- K090385Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009 · cites it directly2descendants
- K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014 · 2 generations on1descendant
- K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015 · 3 generations on0descendants
- K102931G-Cinch Suture GrasperUsgi Medical · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963329 | Ethicon Endosuture System | ETHICON, Inc. | 1996 | — |
| +1 | K060721 | Lariat Loop Applicator | Sentreheart | 2006 | — |
| +1 | K090385 | Lariat II Suture Delivery Device | Sentreheart, Inc. | 2009 | — |
| +2 | K142241 | LARIAT sulture Delivery Device | Sentreheart, Inc. | 2014 | — |
| +3 | K153096 | LARIAT RS Suture Delivery Device | Sentreheart, Inc. | 2015 | — |
| +1 | K102931 | G-Cinch Suture Grasper | Usgi Medical | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | — | ENDOLOOP Ligature with Introducer Named without a submission number | |
| * | — | Pre-Tied Loop Suture Cannula Named without a submission number |
What descends from it? (6)
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?
- Of its descendants, K060721 (Sentreheart, 2006) has gone furthest, with 4 descendants of its own.
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?
Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures.
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/K963329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963329: Ethicon Endosuture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963329
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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