FDA device listing
Monarch Platform, Urology
FDA device listing 1722187029 · Auris Health, Inc.
Key facts
| Proprietary names | Monarch Platform, Urology |
|---|---|
| Owner/operator | Auris Health, Inc. |
| Owner/operator number | 10057462 |
| Premarket submissions | K213334 |
| Product codes | FGA, FGB, GCB, LJE, LJH |
| Device names | FGA - Kit, Nephroscope, FGB - Ureteroscope And Accessories, Flexible/Rigid, GCB - Needle, Catheter, LJE - Catheter, Nephrostomy, LJH - System, Irrigation, Urological |
| Device class | Class I, Class II, Unclassified |
| Classification regulations (21 CFR) | 876.1500, 876.5130, 878.4200, ORCA1.LJE |
| Review panels | Gastroenterology & Urology, General & Plastic Surgery |
| Registered establishments | Auris Health, Inc, Auris Health, Inc. |
| Establishment registrations | 3017425975, 3023460764 |
| FEI numbers | 3014447948, 3023460764 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database