FDA device listing
C.A.P. HD DUODENOSCOPE US (ED34-I10T-US),SINGLE USE DISTAL CAP - ED34-I10T (OE-A62)
FDA device listing 2012847989 · HOYA Corporation PENTAX Division
Key facts
| Proprietary names | C.A.P. HD DUODENOSCOPE US (ED34-I10T-US),SINGLE USE DISTAL CAP - ED34-I10T (OE-A62) |
|---|---|
| Owner/operator | HOYA Corporation PENTAX Division |
| Owner/operator number | 8030235 |
| Premarket submissions | K163614 |
| Product codes | FDT |
| Device names | FDT - Duodenoscope And Accessories, Flexible/Rigid |
| 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