FDA device listing
PLASMAKINETIC SUPERPULSE SYSTEM Footswitch,PLASMAKINETIC SUPERPULSE SYSTEM PK SuperLoop Instrument,PLASMAKINETIC…
FDA device listing 1914572610 · ATL Technology LLC
Key facts
| Proprietary names | PLASMAKINETIC SUPERPULSE SYSTEM Footswitch,PLASMAKINETIC SUPERPULSE SYSTEM PK SuperLoop Instrument,PLASMAKINETIC SUPERPULSE SYSTEM PK SuperSect Instrument,PLASMAKINETIC SUPERPULSE SYSTEM SuperLoop PK Front Loading Electrode,PLASMAKINETIC SUPERPULSE SYSTEM SuperSect PK Front Loading Electrode |
|---|---|
| Owner/operator | ATL Technology LLC |
| Owner/operator number | 10045899 |
| 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 | GYRUS MEDICAL LTD. |
| Establishment registrations | 9617070 |
| FEI numbers | 3002807134 |
| Establishment operations | Contract Manufacturer |
| 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