Class Class II
Single-use Ureteral Access Sheath (K251599)
Description
Single-use Ureteral Access Sheath by Hunan Vathin Medical Instrument Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251599
Clearance Date2025-07-03
Clearance TypeSpecial
Product CodeFED
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251599
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 Ureteral Access Sheath (K251599) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co.... | 2024 |
| K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co.,... | 2021 |
Trace the full predicate network for K251599
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.