DeviceClearance

Product code OCS— Gastroenterology, Urology

STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000

Classification name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“To allow for visualization of body cavities through an endoscope by projecting images to a monitor.”

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

Market context for product code OCS

FDA has cleared 1 device under product code OCS, all in 2010, filed by 1 applicant company. 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.

Top applicants under product code OCS

Recent clearances under product code OCS

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