DeviceClearance

Product code OEW— Neurology

CAS-One Liver

Classification name
Tracking, Soft Tissue, Intraoperative
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
4
First cleared
Most recent

FDA classification definition

“For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.”

— U.S. Food and Drug Administration, device classification record for product code OEW under 21 CFR 882.4560, via openFDA

Market context for product code OEW

FDA has cleared 4 devices under product code OEW between 2007 and 2015, filed by 2 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

Top applicants under product code OEW

Recent clearances under product code OEW

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