FDA device listing
ADAPTER, EYEPIECE/RIGID OCULAR (AP-RV3),ADAPTER, TCH SCOPE, PENTAX TO SCOPE W/RIGID OCULAR (AT-UR2),ADAPTER,TCH SCOPE…
FDA device listing 1921814720 · HOYA Corporation PENTAX Division
Key facts
| Proprietary names | ADAPTER, EYEPIECE/RIGID OCULAR (AP-RV3),ADAPTER, TCH SCOPE, PENTAX TO SCOPE W/RIGID OCULAR (AT-UR2),ADAPTER,TCH SCOPE, RIGID TO PENTAX SCOPE (AT-ST2),CAMERA HEAD (PVK-J10),F16-34 Zoom Coupler (S_413024),VIDEO ADAPTER MODULE EPK W/OUT EYEPIECE (PVK-1070Z),VIVIDEO CAMERA COUPLER (S_081-006),VIVIDEO CAMERA (PVK-CP) |
|---|---|
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| Product codes | FEA |
| Device names | FEA - Attachment, Teaching, For Endoscope |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | HOYA Corporation PENTAX Lifecare Division |
| Establishment registrations | 9610877, 3003782610 |
| FEI numbers | 3003782610, 3008185830 |
| 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 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