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
- 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 | June 24, 2022 |
| K201734 | nasaleze international | AllerBlock Junior | March 26, 2021 |
| K170848 | nasaleze international | Alzair Allergy Blocker | June 14, 2017 |
| K134003 | rhinix aps | RHINIX NASAL FILTER | September 4, 2014 |
| K132520 | hi-tech pharmacal | NASAL EASE ALLERGY BLOCKER | December 31, 2013 |
| K120894 | haymax limited | HAYMAX | May 17, 2012 |
| K053625 | trutek | NASALGUARD | February 22, 2006 |
| K042610 | theiss naturwaren | DR. THEISS ALERGOL POLLEN BLOCKER CREAM | May 16, 2005 |