FDA device listing
AED Albarran Deflectors,AED Bipolar Cutting Loops,AED Bipolar Working Elements,AED HF-Bipolar Resectoscope Cables,AED…
FDA device listing 1146172204 · NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Key facts
| Proprietary names | AED Albarran Deflectors,AED Bipolar Cutting Loops,AED Bipolar Working Elements,AED HF-Bipolar Resectoscope Cables,AED Hystero Resectoscope Cauteries,AED Hystero Resectoscope Hi-Frequency Cables,AED Hystero Resectoscopes,AED Hystero Resectoscope Sheaths,AED Hystero Resectoscope Working Elements,AED Laser Resectoscope,AED Laser Resectoscopes,AED Laser Resectoscope Working Elements,AED Laser Working… |
|---|---|
| Owner/operator | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
| Owner/operator number | 9027397 |
| Premarket submissions | K102663 |
| Product codes | FAS, FDC, FJL |
| Device names | FAS - Electrode, Electrosurgical, Active, Urological, FDC - Resectoscope, Working Element, FJL - Resectoscope |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 876.4300 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
| Establishment registrations | 2085947 |
| FEI numbers | 3000204191 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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