FDA device listing
ABLATOR E-FLEX VULCAN INTEGRATED,ABLATOR MICRO VULCAN INTEGRATED,ABLATOR-S 2MM 60DEG,ABLATOR-S MICRO VULCAN 2MM 60…
FDA device listing 2048217143 · Smith & Nephew, Inc.
Key facts
| Proprietary names | ABLATOR E-FLEX VULCAN INTEGRATED,ABLATOR MICRO VULCAN INTEGRATED,ABLATOR-S 2MM 60DEG,ABLATOR-S MICRO VULCAN 2MM 60 DEG,ABLATOR-S VULCAN 60 DEG,ABLATOR-S VULCAN 90 DEG,ABLATOR-S VULCAN 90 DEG HP,ABLATOR VULCAN 60 DEG,ABLATOR VULCAN 60 DEG 2.0MM,ABLATOR VULCAN 90 DEG HP,CHISEL E-FLEX VULCAN FINISHED STERILE,CHISEL MICRO CURVED VULCAN INTEGRATED,CHISEL MICRO VULCAN ANGLED INTEGRATED,CHISEL MICRO… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K003893 |
| 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 | Arthrocare Corporation, SMITH & NEPHEW INC. |
| Establishment registrations | 1643264, 3003604053, 3012358417 |
| FEI numbers | 1643264, 3003604053, 3012358417 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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