510(k) · Cleared
ClearedNuvis® Wireless HD Camera System (Nuvis-2K)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Endoscopy, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 20, 2025 as substantially equivalent to K213860 (Lazurite Holdings, LLC, 2022) after a 447-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Nov 20, 2025
- Review
- 447 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K950862 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 4 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 3 generations backK132785 Stryker 1488 HD Video Camera with Infrared CompatibilityStryker Endoscopy · 2013 · Recalled
- 2 generations backK142603 Stryker Precision HD Camera SystemStryker Endoscopy · 2014
- 1 generation backK213860 ArthroFree Wireless Surgical Camera SystemLazurite Holdings, LLC · 2022
- This deviceK242606 Nuvis® Wireless HD Camera System (Nuvis-2K)Integrated Endoscopy, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −4 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −3 | K132785 | Stryker 1488 HD Video Camera with Infrared Compatibility | Stryker Endoscopy | 2013 | 3 |
| −2 | K142603 | Stryker Precision HD Camera System | Stryker Endoscopy | 2014 | — |
| −1 | K213860 | ArthroFree Wireless Surgical Camera System | Lazurite Holdings, LLC | 2022 | — |
| 0 (this device) | K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K213860 | ArthroFree Wireless Surgical Camera SystemSummary page 5…Class II Product Code and Review Panel: GCJ; General and Plastic Surgery III. Predicate Device 510(K) Number: K213860 Product Name: ArthroFree Wireless Surgical Camera… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Nuvis Wireless HD Camera System is indicated for use in diagnostic and operative endoscopic procedures, supplying visualization of an interior cavity of the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242606: Nuvis® Wireless HD Camera System (Nuvis-2K).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242606
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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