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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K213334

Monarch Platform, Urology · Auris Health, Inc. · decided 2022-04-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Monarch® Ureteroscopy KitMUR-000011Auris Health, Inc.FGB LJH10810068811053
MONARCH™ Urology Irrigation CartridgeMUR-000016Auris Health, Inc.FGB10810068811107
MONARCH™ Kit Catheter & AccessoriesMUR-000014Auris Health, Inc.GCB10810068811084
MONARCH™Platform, UrologyMON-000007Auris Health, Inc.FGB LJH10810068811046
Monarch®Platform Drape KitMUR-000013Auris Health, Inc.PUI10810068811077
MONARCH™Guided Percutaneous Access KitMUR-000012Auris Health, Inc.GCB10810068811060
MONARCH™ Mini-PCNL Suction SetMUR-000017Auris Health, Inc.FGA10810068811114
MONARCH™ Stone Retrieval BasketMUR-000015Auris Health, Inc.FFL10810068811091
MONARCH™ Ureteroscope ValveMUR-000026Auris Health, Inc.FGB10810068811121