Class Class II
Sphincterotome (K222421)
Description
Sphincterotome by Hangzhou AGS MedTech Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222421
Clearance Date2023-05-03
Clearance TypeTraditional
Product CodeKNS
Regulation Number876.4300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222421
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. Sphincterotome (K222421) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021 |
Trace the full predicate network for K222421
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.