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 Sep 4, 2020 as substantially equivalent to K190645 (Arthrex, Inc., 2019) and 1 other predicate after a 129-day review. Its family tree reaches back 6 generations to 1995. 11 later devices descend from it.
- Decided
- Sep 4, 2020
- Review
- 129 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K950862 (1995). 14 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 5 generations backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- 4 generations backK031098 3-CCD Digital Camera SystemLinvatec Corp. · 2003
- 3 generations backK071756 Endohub- 1.0 Endoscopic Video Camera System with Video CapturePointe Conception Medical, Inc. · 2007
- 2 generations backK153218 Arthrex Synergy UHD4 SystemArthrex, Inc. · 2016
- 1 generation backK190645 Arthrex NanoScope SystemArthrex, Inc. · 2019
- This deviceK201134 Arthrex NanoScope SystemArthrex, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK243008 Arthrex NanoScope SystemArthrex, Inc. · 2025
- Descendant · cites it directly · 4 of its ownK223759 Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK233451 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK241361 Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK252640 VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K243008Arthrex NanoScope SystemArthrex, Inc. · 2025 · cites it directly4descendants
- K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc. · 2023 · cites it directly4descendants
- K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 2 generations on3descendants
- K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc. · 2024 · 3 generations on2descendants
- K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −5 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| −4 | K031098 | 3-CCD Digital Camera System | Linvatec Corp. | 2003 | — |
| −3 | K071756 | Endohub- 1.0 Endoscopic Video Camera System with Video Capture | Pointe Conception Medical, Inc. | 2007 | — |
| −2 | K153218 | Arthrex Synergy UHD4 System | Arthrex, Inc. | 2016 | — |
| −1 | K190645 | Arthrex NanoScope System | Arthrex, Inc. | 2019 | — |
| 0 (this device) | K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 | — |
| +1 | K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025 | — |
| +1 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | — |
| +2 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
| +3 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | — |
| +2 | K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K190645 | Arthrex NanoScope SystemSummary page 4…era System Product Code GCJ, HRX Classification Name 21 CFR 876-1500: Endoscope and accessories Regulatory Class II Predicate Device K190645 – Arthrex NanoScope System K180766 – Endiscope Cervical Purpose of Submission This Traditional 510(… | 2019 |
| * | K180766 | Endiscope, Endiscope CervicalSummary page 4…Name 21 CFR 876-1500: Endoscope and accessories Regulatory Class II Predicate Device K190645 – Arthrex NanoScope System K180766 – Endiscope Cervical Purpose of Submission This Traditional 510(k) premarket notification is submitted to add spine as an add… | 2018 |
| Kept off the family tree | K180299 | FDA’s K180299 is ACUVUE OASYS (senofilcon A) with Photochromic Additive Our reading of the summary gave K180299, FDA’s number for ACUVUE OASYS (senofilcon A) with Photochromic Additive (Johnson & Johnson Vision Care, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Elliquence Endiscope Cervical”. Kept off the family tree. Summary page 4…stantially equivalent to its original K190645 clearance and to the Elliquence Endiscope Cervical system cleared under K180299. Conclusion The proposed Arthrex NanoScope System is substantially equivalent to the predicate… | 2018 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243008 | Arthrex NanoScope System | 2025 | 4 |
| K223759 | Arthrex SynergyID Endoscopic Imaging System | 2023 | 4 |
| K260414 | “Tech-Image” Video Endoscope System | 2026 | 0 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)… | 2025 | 0 |
| K241990 | SpineSite Endoscope System | 2025 | 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 25 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K243008 (Arthrex, Inc., 2025) has gone furthest, with 4 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. 2020, 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 diagnostic and surgical procedures, including but not limited to: orthopedic, spine, 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/K201134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201134: Arthrex NanoScope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201134
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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