NUP — Cream, Nasal, Topical, Mechanical Allergen Particle Barrier Class II
FDA product code NUP covers "Cream, Nasal, Topical, Mechanical Allergen Particle Barrier", a Class II medical device regulated under 21 CFR 880.5045. Submissions are reviewed by the General Hospital panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NUP
- Device Class
- Class II
- Regulation Number
- 880.5045
- Submission Type
- 510(k)
- Review Panel
- EN
- Medical Specialty
- General Hospital
- Implant
- No
Definition
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213114 | Altamira Therapeutics | BentrioTM Allergy Blocker | Jun 24, 2022 |
| K201734 | Nasaleze International | AllerBlock Junior | Mar 26, 2021 |
| K170848 | Nasaleze International | Alzair Allergy Blocker | Jun 14, 2017 |
| K134003 | Rhinix Aps | RHINIX NASAL FILTER | Sep 4, 2014 |
| K132520 | Hi-Tech Pharmacal | NASAL EASE ALLERGY BLOCKER | Dec 31, 2013 |
| K120894 | Haymax Limited | HAYMAX | May 17, 2012 |
| K053625 | Trutek | NASALGUARD | Feb 22, 2006 |
| K042610 | Theiss Naturwaren | DR. THEISS ALERGOL POLLEN BLOCKER CREAM | May 16, 2005 |