510(k) · Cleared
ClearedTrue HD 3MOS Camera System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 9, 2016 as substantially equivalent to K063457 (Conmed Linvatec, 2006) after a 27-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- May 9, 2016
- Review
- 27 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950862 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 3 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 2 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 1 generation backK063457 Truehd (1080P) Digital Camera SystemConmed Linvatec · 2006
- This deviceK161017 True HD 3MOS Camera SystemConmed Corporation · 2016
- Descendant · cites it directly · 0 of its ownK201593 Looking Glass 4K Integrated Visualization SystemConmed Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K201593Looking Glass 4K Integrated Visualization SystemConmed Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −3 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −2 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −1 | K063457 | Truehd (1080P) Digital Camera System | Conmed Linvatec | 2006 | — |
| 0 (this device) | K161017 | True HD 3MOS Camera System | Conmed Corporation | 2016 | — |
| +1 | K201593 | Looking Glass 4K Integrated Visualization System | Conmed Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K063457 | Truehd (1080P) Digital Camera SystemSummary page 4…Device Name: ConMed 3-CCD High Definition Digital Camera System Company Name: ConMed Corporation 510(k) #: K063457 V. DEVICE DESCRIPTION Modified Device The ConMed True HD 3MOS Camera System consists of a camera con… | 2006 |
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 |
|---|---|---|---|
| K201593 | Looking Glass 4K Integrated Visualization System | 2020 | 0 |
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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K201593 (Conmed Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063457.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ConMed True HD 3MOS Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161017: True HD 3MOS Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161017
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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