NUP · Class II · 21 CFR 880.5045

FDA Product Code NUP: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

The Device Is Intended To Promote Alleviation Of Mild Allergic Symptoms Triggered By The Inhalation Of Various Allergens.

Leading manufacturers include Nasaleze International, Ltd. and Altamira Therapeutics, Inc..

8
Total
8
Cleared
171d
Avg days
2005
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Cream, Nasal, Topical, Mechanical Allergen Particle Barrier Devices (Product Code NUP)

8 devices
1–8 of 8

About Product Code NUP - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code NUP since 2005, with 8 receiving FDA clearance (average review time: 171 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

NUP devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →