510(k) Report

Devices descending from K230200

2 later devices reach Single-Use Flexible Ureteroscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243155Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03…Dongguan Zsr Biomedical Technology Company Limited20250—
+1K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5…Hunan Endoso Life Technology Co., Ltd.20250—