DeviceClearance

Product code NXH— General Hospital

SOOTHIES GEL PADS

Classification name
Nursing Pad, Cohesive Gel
Device class
Class 1
Regulation
21 CFR 880.5630
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended to relieve nipples that are sore and cracked from breast feeding.”

— U.S. Food and Drug Administration, device classification record for product code NXH under 21 CFR 880.5630, via openFDA

Market context for product code NXH

FDA has cleared 1 device under product code NXH, all in 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code NXH

Recent clearances under product code NXH

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