Product code ENW— Ear, Nose, Throat

SILICONE SOFT-PAK EPISTAXIS CATHETER

Classification name
Catheter, Nasopharyngeal
Device class
Class 1
Regulation
21 CFR 874.4175
Advisory panel
Ear, Nose, Throat
Total cleared
2
First cleared
Most recent

Market context for product code ENW

FDA has cleared 2 devices under product code ENW between 1983 and 1985, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code ENW

Recent clearances under product code ENW

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