DeviceClearance

Product code NWO— Gastroenterology, Urology

ICATH, STERILESURE

Classification name
Kit, Catheter, Urinary (Exludes Hiv Testing)
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Urinary Catheterization Kit (Excludes HIV Testing)”

— U.S. Food and Drug Administration, device classification record for product code NWO under 21 CFR 876.5130, via openFDA

Market context for product code NWO

FDA has cleared 1 device under product code NWO, all in 2007, 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 NWO

Recent clearances under product code NWO

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