510(k) · Cleared
ClearedModification to Intuitive Surgical Stereo View Endoscopic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 24, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 24, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK001666 Modification to Intuitive Surgical Stereo View Endoscopic SystemIntuitive Surgical, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK080155 Modification to:Intuitive Surgical Stereo View Endoscopic SystemIntuitive Surgical, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK191043 da Vinci Handheld CameraIntuitive Surgical, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK241913 da Vinci Handheld CameraIntuitive Surgical Operations, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK170641 da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK013952 Intuitive Surgical Stero View Endoscopic SystemIntuitive Surgical, Inc. · 2002
Most influential descendants
Showing 5 of 5 · See all- K080155Modification to:Intuitive Surgical Stereo View Endoscopic SystemIntuitive Surgical, Inc. · 2008 · cites it directly3descendants
- K191043da Vinci Handheld CameraIntuitive Surgical, Inc. · 2019 · 2 generations on1descendant
- K241913da Vinci Handheld CameraIntuitive Surgical Operations, Inc. · 2024 · 3 generations on0descendants
- K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017 · 2 generations on0descendants
- K013952Intuitive Surgical Stero View Endoscopic SystemIntuitive Surgical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001666 | Modification to Intuitive Surgical Stereo View Endoscopic System | Intuitive Surgical, Inc. | 2000 | — |
| +1 | K080155 | Modification to:Intuitive Surgical Stereo View Endoscopic System | Intuitive Surgical, Inc. | 2008 | — |
| +2 | K191043 | da Vinci Handheld Camera | Intuitive Surgical, Inc. | 2019 | 1 |
| +3 | K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | 2024 | — |
| +2 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | Intuitive Surgical, Inc. | 2017 | — |
| +1 | K013952 | Intuitive Surgical Stero View Endoscopic System | Intuitive Surgical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (5)
2 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, K080155 (Intuitive Surgical, Inc., 2008) has gone furthest, with 3 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/K001666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001666: Modification to Intuitive Surgical Stereo View Endoscopic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001666
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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