Class Class II
Arthrex NanoScope System (K243008)
Description
Arthrex NanoScope System by Arthrex, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243008
Clearance Date2025-01-22
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243008
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Arthrex NanoScope System (K243008) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM S... | Stryker | 2021 |
| K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2025 |
Trace the full predicate network for K243008
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.