ODA

Endoscopic Central Control Unit

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-03.

NumberDecision dateApplicantDevice nameSummary
K2324062023-10-03Karl Storz SE & CO. KGKARL STORZ OR1™ SCB CONTROL (WU300)PDF

1 summaries are archived here for direct download.

Official FDA classification page: ODA
Classification and pathway per current FDA publications. Data from openFDA (CC0).