510(k) · Cleared
ClearedArthrex NanoScope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 5, 2019 as substantially equivalent to K153218 (Arthrex, Inc., 2016) after a 114-day review. Its family tree reaches back 5 generations to 1995. 12 later devices descend from it.
- Decided
- Jul 5, 2019
- Review
- 114 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K950862 (1995). 6 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- 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 backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 2 generations backK071756 Endohub- 1.0 Endoscopic Video Camera System with Video CapturePointe Conception Medical, Inc. · 2007
- 1 generation backK153218 Arthrex Synergy UHD4 SystemArthrex, Inc. · 2016
- This deviceK190645 Arthrex NanoScope SystemArthrex, Inc. · 2019
- Descendant · cites it directly · 11 of its ownK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK243008 Arthrex NanoScope SystemArthrex, Inc. · 2025
- Descendant · 2 generations on · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK233451 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
- Descendant · 4 generations on · 2 of its ownK241361 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K201134Arthrex NanoScope SystemArthrex, Inc. · 2020 · cites it directly11descendants
- K243008Arthrex NanoScope SystemArthrex, Inc. · 2025 · 2 generations on4descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · 2 generations on4descendants
- K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 3 generations on3descendants
- K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 4 generations on2descendants
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 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −2 | K071756 | Endohub- 1.0 Endoscopic Video Camera System with Video Capture | Pointe Conception Medical, Inc. | 2007 | — |
| −1 | K153218 | Arthrex Synergy UHD4 System | Arthrex, Inc. | 2016 | — |
| 0 (this device) | K190645 | Arthrex NanoScope System | Arthrex, Inc. | 2019 | — |
| +1 | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| +2 | K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025 | — |
| +2 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
| +3 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
| +4 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
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 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K153218 | Arthrex Synergy UHD4 SystemSummary page 4…Product Code GCJ Classification Name 21 CFR 876-1500: Endoscope and accessories Regulatory Class II Predicate Device K153218 – Arthrex Synergy UHD4 System Purpose of Submission This Special 510(k) premarket notification is submitted to obtain cle… | 2016 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201134 | Arthrex NanoScope System | 2020 | 11 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K201134 (Arthrex, Inc., 2020) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K153218.
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 Arthrex NanoScope system is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190645: Arthrex NanoScope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190645
Report an extraction error
Are you the manufacturer?
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