FDA device listing
PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15,PENTAX Medical Air/Water feeding Valve OE-B12,PENTAX Medical…
FDA device listing 1418477107 · HOYA Corporation PENTAX Division
Key facts
| Proprietary names | PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15,PENTAX Medical Air/Water feeding Valve OE-B12,PENTAX Medical Cylinder Cleaning Adapter (OE-B16),PENTAX Medical Keyboard EN OS-A115,PENTAX Medical Suction control valve OE-B13,PENTAX Medical Video Processor EPK-i8020c,PENTAX Medical Video Upper GI Scope EG29- i20c,PENTAX Medical Water Jet Channel Cleaning Adapter OE-C31,Pentax Video… |
|---|---|
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| Premarket submissions | K231249 |
| Product codes | FDF, FDS, PEA |
| Device names | FDF - Colonoscope And Accessories, Flexible/Rigid, FDS - Gastroscope And Accessories, Flexible/Rigid, PEA - Endoscope, Accessories, Image Post-Processing For Color Enhancement |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | HOYA Corporation PENTAX Lifecare Division, PENTAX MEDICAL (PENANG) SDN. BHD. |
| Establishment registrations | 9610877, 3003782610, 3014605202 |
| FEI numbers | 3003782610, 3008185830, 3014605202 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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