510(k) · Cleared
Cleared3-CCD Digital Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envision Medical Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 22, 1997 after a 93-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 125 later devices descend from it.
- Decided
- May 22, 1997
- Review
- 93 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
125 later devices descend from it, 1 citing it directly.
- This deviceK970605 3-CCD Digital CameraEnvision Medical Corp. · 1997
- Descendant · cites it directly · 124 of its ownK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- Descendant · 2 generations on · 116 of its ownK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
- Descendant · 3 generations on · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
- Descendant · 5 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K0310983-CCD Digital Camera SystemLinvatec Corp. · 2003 · cites it directly124descendants
- K063457Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006 · 2 generations on116descendants
- K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · 3 generations on106descendants
- K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 4 generations on104descendants
- K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 5 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970605 | 3-CCD Digital Camera | Envision Medical Corp. | 1997 | — |
| +1 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| +2 | K063457 | Truehd (1080P) Digital Camera System | Conmed Linvatec | 2006 | — |
| +3 | K091515 | Spy Scope Intra-Operative Operating System | Novadaq Technologies, Inc. | 2009 | 1 |
| +4 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
| +5 | K124031 | DA Vinci Fluorescence Imaging Vision System | Intuitive Surgical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 20 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K941919 | FDA’s K941919 is Oktas Endoscopy Video Camera System Our OCR of the scanned summary read K941919, FDA’s number for Oktas Endoscopy Video Camera System (Oktas), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 1…is comparable to that of other legally marketed video camera systems. The design was based upon a predicate device that was found to be substantially equivalent in 510K (K941919). Vyol77- General Manager I it Flhf.r:, ! { ¥ I Txrme é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Healt… | 1994 |
What descends from it? (125)
See all 1251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031098 | 3-CCD Digital Camera System | 2003 | 124 |
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, K031098 (Linvatec Corp., 2003) has gone furthest, with 124 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 | — |
What is it indicated for?
The 3-CCD Digital Camera System provides medical professionals
with video capabilities for diagnostic and surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970605: 3-CCD Digital Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970605
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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