DeviceClearance

Product code HNX— Ophthalmic

FMS ARTHRO-CUTTER

Classification name
Depressor, Orbital
Device class
Class 1
Regulation
21 CFR 886.4350
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

Market context for product code HNX

FDA has cleared 2 devices under product code HNX, all in 1995, 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 HNX

Recent clearances under product code HNX

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