Class Class II
Single-Use Flexible Ureteroscope (K230200)
Description
Single-Use Flexible Ureteroscope by Hunan Vathin Medical Instrument Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230200
Clearance Date2023-05-18
Clearance TypeTraditional
Product CodeFGB
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230200
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. Single-Use Flexible Ureteroscope (K230200) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co.... | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243155 | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01... | Dongguan Zsr Biomedical Technology ... | 2025 |
| K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2,... | Hunan Endoso Life Technology Co., Ltd. | 2025 |
Trace the full predicate network for K230200
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.