K230142 is an FDA 510(k) clearance for the Epi-Stop Nasal Gel/epistaxis pack. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Biomed Ent, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 22, 2023, 63 days after receiving the submission on January 18, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K230142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2023 |
| Decision Date | March 22, 2023 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | LYA - Splint, Intranasal Septal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4780 |