FDA device listing
VAPR 2.3 Wedge Electrode with Integrated Handpiece,VAPR Hook Electrode with Integrated Handpiece,VAPR Premiere50…
FDA device listing 1143955999 · ATL Technology LLC
Key facts
| Proprietary names | VAPR 2.3 Wedge Electrode with Integrated Handpiece,VAPR Hook Electrode with Integrated Handpiece,VAPR Premiere50 Electrode Integrated Handpiece,VAPR S90 Electrode with Integrated Handpiece,VAPR Side Effect Electrode with Integrated Handpiece |
|---|---|
| Owner/operator | ATL Technology LLC |
| Owner/operator number | 10045899 |
| Product codes | GEI, HRX |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories, HRX - Arthroscope |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400, 888.1100 |
| Review panels | General & Plastic Surgery, Orthopedic |
| 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