510(k) · Cleared
Recalled · Class II · 2019da Vinci Handheld Camera
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 Jun 6, 2019 as substantially equivalent to K080155 (Intuitive Surgical, Inc., 2008) after a 48-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 6, 2019
- Review
- 48 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001666 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001666 Modification to Intuitive Surgical Stereo View Endoscopic SystemIntuitive Surgical, Inc. · 2000
- 1 generation backK080155 Modification to:Intuitive Surgical Stereo View Endoscopic SystemIntuitive Surgical, Inc. · 2008
- This deviceK191043 da Vinci Handheld CameraIntuitive Surgical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK241913 da Vinci Handheld CameraIntuitive Surgical Operations, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241913da Vinci Handheld CameraIntuitive Surgical Operations, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K191043 | da Vinci Handheld Camera | Intuitive Surgical, Inc. | 2019 | — |
| +1 | K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K080155 | Modification to:Intuitive Surgical Stereo View Endoscopic SystemSummary page 4…ory Committee: General and Plastic Surgery Predicate Device: Intuitive Surgical Stereo View Endoscopic System (K080155) Device Description The da Vinci Handheld Camera is a lightweight handheld 2D Camera which can be connected to any third party 5… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241913 | da Vinci Handheld Camera | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2019 | Class II | Z-2329-2020 | Device Design | Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 1 company; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241913 (Intuitive Surgical Operations, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080155.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191043: da Vinci Handheld Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191043
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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