DeviceClearance

Product code LRC— Ear, Nose, Throat

XPRESS MULTI-SINUS DILATION TOOL

Classification name
Instrument, Ent Manual Surgical
Device class
Class 1
Regulation
21 CFR 874.4420
Advisory panel
Ear, Nose, Throat
Total cleared
65
First cleared
Most recent

Market context for product code LRC

FDA has cleared 65 devices under product code LRC between 1987 and 2023, filed by 24 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 LRC

Adverse events under product code LRC

product code LRC
Death
5
Total
5

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LRC

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