DeviceClearance

Product code ODA— Gastroenterology, Urology

IDSS ForceTriad Control Module

Classification name
Endoscopic Central Control Unit
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
18
First cleared
Most recent

FDA classification definition

“To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.”

— U.S. Food and Drug Administration, device classification record for product code ODA under 21 CFR 876.1500, via openFDA

Market context for product code ODA

FDA has cleared 18 devices under product code ODA between 1998 and 2023, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ODA

Recent clearances under product code ODA

Data sourced from openFDA. This site is unofficial and independent of the FDA.