Mountain Ash, GB · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 1 | 2026-09-02 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Class II | Anesthesiology | 1 | 2026-01-16 |
| BTR | Tube, Tracheal (W/Wo Connector) | Class II | Anesthesiology | 1 | 2025-05-20 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | Class II | Anesthesiology | 1 | 2020-11-13 |
| CAH | Filter, Bacterial, Breathing-Circuit | Class II | Anesthesiology | 1 | 2020-03-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-02 | K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | EOQ | Class II | Ear, Nose, Throat |
| 2026-01-16 | K251448 | FL-10000U Respiratory Humidifier | BTT | Class II | Anesthesiology |
| 2025-05-20 | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | BTR | Class II | Anesthesiology |
| 2020-11-13 | K201666 | SINGLE USE MANOMETER | CAP | Class II | Anesthesiology |
| 2020-03-23 | K191909 | HepaShield Bacterial Viral Breathing System Filter | CAH | Class II | Anesthesiology |