DeviceClearance

Product code LYA— Ear, Nose, Throat

SPIWay Endonasal Access Guide

Classification name
Splint, Intranasal Septal
Device class
Class 1
Regulation
21 CFR 874.4780
Advisory panel
Ear, Nose, Throat
Total cleared
46
First cleared
Most recent

Market context for product code LYA

FDA has cleared 46 devices under product code LYA between 1983 and 2025, filed by 33 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

last 15 years

Top applicants under product code LYA

Recent clearances under product code LYA

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