FDA device listing
Aptra™ Digital Endoscope System,Aptra™ Image System,Aptra™ Single-Use Digital Flexible Ureteroscope,WiScope® Digital…
FDA device listing 1095549457 · OTU MEDICAL INC.
Key facts
| Proprietary names | Aptra™ Digital Endoscope System,Aptra™ Image System,Aptra™ Single-Use Digital Flexible Ureteroscope,WiScope® Digital Endoscope System,WiScope® Image System,WiScope® Single-Use Digital Flexible Ureteroscope,WiScope® Single-Use Digital Flexible UroScope |
|---|---|
| Owner/operator | OTU MEDICAL INC. |
| Owner/operator number | 10058788 |
| Premarket submissions | K181977 |
| Product codes | FGB |
| Device names | FGB - Ureteroscope And Accessories, Flexible/Rigid |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | OTU Medical Inc |
| Establishment registrations | 3013992977 |
| FEI numbers | 3013992977 |
| 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