Intersect ENT, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0167-2023Class IIISINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 15January 4, 2023
Z-0458-2023Class IIPropel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044October 21, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K212774VenSure LightGuideFebruary 4, 2022