FDA device listing
Low energy direct current thermal ablation system
FDA device listing 1978423040 · LYNX Medical NJ
Key facts
| Proprietary names | Low energy direct current thermal ablation system |
|---|---|
| Owner/operator | LYNX Medical NJ |
| Owner/operator number | 10094683 |
| Product codes | OAB |
| Device names | OAB - Low Energy Direct Current Thermal Ablation System |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | LYNX Medical NJ |
| Establishment registrations | 2244478 |
| FEI numbers | 1000136269 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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