Class Class II
Endoscopic Camera System (K250204)
Description
Endoscopic Camera System by Shenzhen Sophway Technology Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250204
Clearance Date2025-07-01
Clearance TypeTraditional
Product CodeFET
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250204
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. Endoscopic Camera System (K250204) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016 |
Trace the full predicate network for K250204
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.