K243138 is an FDA 510(k) clearance for the Geon (S2) Nasal Aspirator. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Geon Corporation (Chang Hwa Hsien, TW). The FDA issued a Cleared decision on February 4, 2025, 127 days after receiving the submission on September 30, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K243138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | February 04, 2025 |
| Days to Decision | 127 days |
| Submission Type | Special |
| 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 |