510(k) Report

Devices descending from K951855

28 later devices reach Ultrathin Ureteroscopes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033651Olympus Video Ureteroscope, NTSCOlympus Winter & Ibe GmbH200426—
+1K973232Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated…Olympus Winter & Ibe GmbH19970—
+2K153049LithoVue SystemBoston Scientific Corporation201524—
+2K121112Stryker Video UreteroscopeStryker Endoscopy20120—
+3K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+3K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…Gyrus Acmi, Inc.20240—
+3K223097RenaNav Ureteroscope SystemCenterPoint Systems, LLC20230—
+3K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation20234—
+3K213334Monarch Platform, UrologyAuris Health, Inc.202201
+3K211347Uretero1 Ureteroscope SystemSTERIS Corporation20213—
+3K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20189—
+4K242108Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20240—
+4K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation20241—
+4K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+4K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation -202331
+4K223466Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20232—
+4K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.20204—
+5K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+5K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation20260—
+5K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+5K260013CVAC Image ProcessorCalyxo, Inc.20260—
+5K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation20250—
+5K231878Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101…STERIS Corporation20231—
+5K220159Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model…Shanghai AnQing Medical Instrument Co., Ltd.20223—
+6K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope…Opcom Medical, Inc.20250—
+6K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20251—
+6K222737Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)Shanghai AnQing Medical Instrument Co., Ltd.20220—
+7K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…Shanghai AnQing Medical Instrument Co., Ltd.20250—