FDA device listing
E2580-28 Argon Plus Laparoscopic Blade Electrode, Retractable, 11,E2581-28 Argon Plus Laparoscopic Modified Flat-L…
FDA device listing 1903251275 · Terumo BCT, INC.
Key facts
| Proprietary names | E2580-28 Argon Plus Laparoscopic Blade Electrode, Retractable, 11,E2581-28 Argon Plus Laparoscopic Modified Flat-L Electrode, Retractable, 11,E2582-28 Argon Plus Laparoscopic Tungsten Sharp Needle Electrode, Retractable, 11,E2583-28 Argon Plus Laparoscopic Tungsten Blunt Needle Electrode, Retractable, 11 |
|---|---|
| Owner/operator | Terumo BCT, INC. |
| Owner/operator number | 9002708 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Terumo BCT STERILIZATION SERVICES, Inc. |
| Establishment registrations | 1724474 |
| FEI numbers | 3003094851 |
| 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