DeviceClearance

Product code NWS— Gastroenterology, Urology

FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE

Classification name
Kit, Choledochoscope, Flexible And Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Flexible and Rigid Choledochoscope Kit”

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

Market context for product code NWS

FDA has cleared 1 device under product code NWS, all in 1981, 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 NWS

Recent clearances under product code NWS

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