Class Class II
Arthrex SynergyID Endoscopic Imaging System (K223759)
Description
Arthrex SynergyID Endoscopic Imaging System by Arthex, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223759
Clearance Date2023-02-24
Clearance TypeTraditional
Product CodeGCJ
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223759
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 SynergyID Endoscopic Imaging System (K223759) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202582 | Arthrex SynergyID Endoscopic Imaging System | Arthrex, Inc. | 2021 |
| K201526 | TIPCAM1 Rubina Video Endoscope System | Karl Storz Endoscopy America | 2020 |
| K201134 | Arthrex NanoScope System | Arthrex, Inc. | 2020 |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Pa... | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 |
Trace the full predicate network for K223759
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.