FDA device listing
BLACK FOCUS RING, 19.5MM FOCAL LENGTH, 4.0MM OD, 30 DEG DIRECTION OF VIEW, 115 DEG FIELD OF VIEW, 160MM, OPPOSITE…
FDA device listing 1656579402 · Smith & Nephew, Inc.
Key facts
| Proprietary names | BLACK FOCUS RING, 19.5MM FOCAL LENGTH, 4.0MM OD, 30 DEG DIRECTION OF VIEW, 115 DEG FIELD OF VIEW, 160MM, OPPOSITE, J-LOC,BLACK FOCUS RING, 19.5MM FOCAL LENGTH, 4.0MM OD, 30 DEG DIRECTION OF VIEW, 115 DEG FIELD OF VIEW, 160MM, SAME SIDE, J-LO,BLACK FOCUS RING, 19.5MM FOCAL LENGTH, 4.0MM OD, 70 DEG DIRECTION OF VIEW, 115 DEG FIELD OF VIEW, 160MM, SAME SIDE, J-LO,VIDEOARTHROSCOPE, BLACK FOCUS RING… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K043395 |
| Product codes | EOB, HRX |
| Device names | EOB - Nasopharyngoscope (Flexible Or Rigid), HRX - Arthroscope |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4760, 888.1100 |
| Review panels | Ear, Nose, & Throat, Orthopedic |
| Registered establishments | SMITH & NEPHEW INC. |
| Establishment registrations | 3003604053 |
| FEI numbers | 3003604053 |
| Establishment operations | 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