510(k) Report

Devices descending from K221515

4 later devices reach StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+1K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+2K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+2K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—