510(k) · Cleared
Recalled · Class II · 2013Evacuation/Irrigation/Elecrosurgical Device
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 21, 1991 after a 139-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it. It has been recalled 22 times.
- Decided
- Oct 21, 1991
- Review
- 139 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 22
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK912492 Evacuation/Irrigation/Elecrosurgical DeviceETHICON, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK160128 Endopath Electrosurgery Probe Plus IIEthicon Endo-Surgery, LLC · 2016
- Descendant · cites it directly · 2 of its ownK082955 Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK971146 LaparetteRd Chus, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK250400 Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK180031 Endopath Electrosurgery Probe Plus IIEthicon Endo-Surgery, LLC · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
1997high 3 (2009) · low 0 (1998)2026
Most influential descendants
Showing 5 of 8 · See all- K160128Endopath Electrosurgery Probe Plus IIEthicon Endo-Surgery, LLC · 2016 · cites it directly2descendants
- K082955Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505Ethicon Endo-Surgery, Inc. · 2009 · cites it directly2descendants
- K971146LaparetteRd Chus, Inc. · 1997 · cites it directly1descendant
- K250400Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K180031Endopath Electrosurgery Probe Plus IIEthicon Endo-Surgery, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912492 | Evacuation/Irrigation/Elecrosurgical Device | ETHICON, Inc. | 1991 | — |
| +1 | K160128 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | 2016 | — |
| +1 | K082955 | Ethicon Endo-Surgery Articulating Hook Knife, Model IN4505 | Ethicon Endo-Surgery, Inc. | 2009 | — |
| +1 | K971146 | Laparette | Rd Chus, Inc. | 1997 | — |
| +2 | K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | 2025 | — |
| +2 | K180031 | Endopath Electrosurgery Probe Plus II | Ethicon Endo-Surgery, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2013 | Class II | Z-1772-2013 | Packaging | The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device. |
| Dec 9, 2008 | Not classified | Z-0655-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0656-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0659-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0660-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0657-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0658-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0661-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0662-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Dec 9, 2008 | Not classified | Z-0663-2009 | Process design | Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel… |
| Apr 20, 2006 | Not classified | Z-0917-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0924-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0925-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0926-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0921-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0919-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0920-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0915-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0916-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0918-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0922-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Apr 20, 2006 | Not classified | Z-0923-06 | Packaging process control | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
The 5 latest of 22 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160128 (Ethicon Endo-Surgery, LLC, 2016) has gone furthest, with 2 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
2007high 31 (2023) · low 15 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
2007high 122 (2010) · low 42 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
2007high 30 (2010) · low 0 (2015)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
2007high 6,047 (2024) · low 1,319 (2008)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/K912492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912492: Evacuation/Irrigation/Elecrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912492
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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