Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (K233778)
Description
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) by Zhuhai Pusen Medical Technology Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233778
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 Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (K233778) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2020 |
| K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co.... | 2017 |
Trace the full predicate network for K233778
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.