510(k) · Cleared
ClearedEndopath Endoscopic Surgical Instruments
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 Jun 22, 1993 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jun 22, 1993
- Review
- 119 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 5 citing it directly.
- This deviceK930933 Endopath Endoscopic Surgical InstrumentsETHICON, Inc. · 1993
- Descendant · cites it directly · 5 of its ownK061276 G-Prox Endoscopic GrasperUsgi Medical · 2006
- Descendant · cites it directly · 2 of its ownK061268 G-Lix Tissue GrasperUsgi Medical · 2006
- Descendant · cites it directly · 2 of its ownK012625 Reprocessed Unipolar Laparoscopic/Endoscopic InstrumentsAlliance Medical Corp. · 2001
- Descendant · 2 generations on · 1 of its ownK100251 G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010
- Descendant · 2 generations on · 1 of its ownK093018 G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K061276G-Prox Endoscopic GrasperUsgi Medical · 2006 · cites it directly5descendants
- K061268G-Lix Tissue GrasperUsgi Medical · 2006 · cites it directly2descendants
- K012625Reprocessed Unipolar Laparoscopic/Endoscopic InstrumentsAlliance Medical Corp. · 2001 · cites it directly2descendants
- K100251G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333Usgi Medical · 2010 · 2 generations on1descendant
- K093018G-Prox Endoscopic Grasper, Model 205333Usgi Medical · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930933 | Endopath Endoscopic Surgical Instruments | ETHICON, Inc. | 1993 | — |
| +1 | K061276 | G-Prox Endoscopic Grasper | Usgi Medical | 2006 | — |
| +1 | K061268 | G-Lix Tissue Grasper | Usgi Medical | 2006 | — |
| +1 | K012625 | Reprocessed Unipolar Laparoscopic/Endoscopic Instruments | Alliance Medical Corp. | 2001 | — |
| +2 | K100251 | G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333 | Usgi Medical | 2010 | — |
| +2 | K093018 | G-Prox Endoscopic Grasper, Model 205333 | Usgi Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 145 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, K061276 (Usgi Medical, 2006) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K930933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930933: Endopath Endoscopic Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930933
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026