510(k) · Cleared
Cleared“Tech-Image” Video Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tech-Image CO., LTD. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 10, 2026 as substantially equivalent to K201134 (Arthrex, Inc., 2020) and 1 other predicate after a 121-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jun 10, 2026
- Review
- 121 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K950862 (1995). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 6 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 5 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 4 generations backK071756 Endohub- 1.0 Endoscopic Video Camera System with Video CapturePointe Conception Medical, Inc. · 2007
- 3 generations backK153218 Arthrex Synergy UHD4 SystemArthrex, Inc. · 2016
- 2 generations backK190645 Arthrex NanoScope SystemArthrex, Inc. · 2019
- 1 generation backK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- This deviceK260414 “Tech-Image” Video Endoscope SystemTech-Image CO., LTD. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −6 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −5 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −4 | K071756 | Endohub- 1.0 Endoscopic Video Camera System with Video Capture | Pointe Conception Medical, Inc. | 2007 | — |
| −3 | K153218 | Arthrex Synergy UHD4 System | Arthrex, Inc. | 2016 | — |
| −2 | K190645 | Arthrex NanoScope System | Arthrex, Inc. | 2019 | — |
| −1 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K201134 | Arthrex NanoScope SystemSummary page 5…ty Gastroenterology/Urology Submission Type Traditional 510(k) Predicate Device K201134 Secondary Predicate K203226 K260414… | 2020 |
| * | K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…Summary page 5…Type Traditional 510(k) Predicate Device K201134 Secondary Predicate K203226 K260414 Page 2 of 8 SECTION… | 2021 |
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 31 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 4 other devices also cite its predicate K201134.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 “Tech-Image” Video Endoscope System is intended to be used as a single-use endoscopic video camera to provide visualization of the interior of the body’s internal anatomy during various diagnostic and surgical endoscopic procedures. These applications include, but are not limited to: general surgery and minimally invasive surgery (e.g., orthopedic, spine, laparoscopic, and plastic 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/K260414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260414: “Tech-Image” Video Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260414
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026