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 Mar 6, 2008 as substantially equivalent to K001666 (Intuitive Surgical, Inc., 2000) after a 43-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Mar 6, 2008
- Review
- 43 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001666 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK001666 Modification to Intuitive Surgical Stereo View Endoscopic SystemIntuitive Surgical, Inc. · 2000
- This deviceK080155 Modification to:Intuitive Surgical Stereo View Endoscopic SystemIntuitive Surgical, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK191043 da Vinci Handheld CameraIntuitive Surgical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK241913 da Vinci Handheld CameraIntuitive Surgical Operations, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK170641 da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K191043da Vinci Handheld CameraIntuitive Surgical, Inc. · 2019 · cites it directly1descendant
- K241913da Vinci Handheld CameraIntuitive Surgical Operations, Inc. · 2024 · 2 generations on0descendants
- K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001666 | Modification to Intuitive Surgical Stereo View Endoscopic System | Intuitive Surgical, Inc. | 2000 | — |
| 0 (this device) | K080155 | Modification to:Intuitive Surgical Stereo View Endoscopic System | Intuitive Surgical, Inc. | 2008 | — |
| +1 | K191043 | da Vinci Handheld Camera | Intuitive Surgical, Inc. | 2019 | 1 |
| +2 | K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | 2024 | — |
| +1 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | Intuitive Surgical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K001666 | Modification to Intuitive Surgical Stereo View Endoscopic System | 2000 |
What descends from it? (3)
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?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical ® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080155: 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 4, 2026. https://510kreport.com/device/K080155
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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