510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NUPClass II

Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

21 CFR 880.5045 / General Hospital
FDA source (opens on fda.gov)

NUP is the FDA product code for Cream, Nasal, Topical, Mechanical Allergen Particle Barrier, a class II device type, regulated under 21 CFR 880.5045. FDA's definition for this code reads: "THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NUP
Device name
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
FDA definition
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code NUP

By decision year
8 clearances under product code NUP with a decision year between 2005 and 2022, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NUP by decision year
YearClearances
20051
20061
20121
20131
20141
20171
20211
20221

Applicants with the most clearances

Product code NUP
Applicants holding the most 510(k) clearances under product code NUP
ApplicantClearances
Nasaleze International, Ltd.2
Altamira Therapeutics, Inc.1
Dr. Theiss Naturwaren GmbH1
Haymax Limited1
Hi-Tech Pharmacal, Inc.1
Rhinix ApS1
Trutek Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code