510(k) Report

Devices descending from K153049

24 later devices reach LithoVue System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+1K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+1K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+1K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+1K213334Monarch Platform, UrologyAuris Health, Inc.202201
+1K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+1K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+2K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+2K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+2K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+2K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+2K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20232—
+2K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20204—
+3K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+3K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+3K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+3K260013CVAC Image ProcessorCalyxo, Inc.20260—
+3K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—
+3K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20231—
+3K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model…Shanghai AnQing Medical Instrument Co., Ltd.20223—
+4K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…Opcom Medical, Inc.20250—
+4K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20251—
+4K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+5K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—