Class Class II
Disposable ureteral stent (K243830)
Description
Disposable ureteral stent by Shenzhen Trious Medical Technology Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243830
Clearance Date2025-05-14
Clearance TypeTraditional
Product CodeFAD
Regulation Number876.4620
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243830
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. Disposable ureteral stent (K243830) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, REL... | Ureteral Stent Company | 2022 |
| K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 |
Trace the full predicate network for K243830
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.