FDA device listing
EvoTech Integrated Endoscope Disinfection System (50004)
FDA device listing 1142982758 · Advanced Sterilization Products
Key facts
| Proprietary names | EvoTech Integrated Endoscope Disinfection System (50004) |
|---|---|
| Owner/operator | Advanced Sterilization Products |
| Owner/operator number | 9068155 |
| Premarket submissions | K082392 |
| Product codes | FEB |
| Device names | FEB - Accessories, Cleaning, For Endoscope |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | ADVANCED STERILIZATION PRODUCTS |
| Establishment registrations | 2084725 |
| FEI numbers | 3003662624 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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