ODA
- Product code
- ODA
- Device name
- Endoscopic Central Control Unit
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 18 (all years; only the last 3 years are listed here)
FDA classification definition
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232406 | 2023-10-03 | Karl Storz SE & CO. KG | KARL STORZ OR1 SCB CONTROL (WU300) |
Official FDA classification page: ODA
Classification and pathway per current FDA publications. Data from openFDA (CC0).