DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in the market. The assembly system (control unit & DS-10EA Adapter & existing endoscope in the…
DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in the market. The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of the body.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Digital Medical Scope | Listed by | Nidek Incorporated, United States |
| FDA product code | FTT |
| Device type | Camera, Still, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-31 |
| Record revised | 2026-04-10 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2023-10-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.