K241852 is an FDA 510(k) clearance for the Nasal Aspirator (NS 13). This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on December 31, 2024, 187 days after receiving the submission on June 27, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K241852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2024 |
| Decision Date | December 31, 2024 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |