Class Class II
Arthrex Synergy Vision Endoscopic Imaging System (K250728)
Description
Arthrex Synergy Vision Endoscopic Imaging System by Arthrex, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250728
Clearance Date2025-05-05
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250728
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 Synergy Vision Endoscopic Imaging System (K250728) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025 |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 |
Trace the full predicate network for K250728
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.