K220326 is an FDA 510(k) clearance for the PosiSep X BAM Hemostat Dressing/Intranasal Splint. This device is classified as a Balloon, Epistaxis (Class I - General Controls, product code EMX).
Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on November 14, 2022, 283 days after receiving the submission on February 4, 2022.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4100.
| 510(k) Number | K220326 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2022 |
| Decision Date | November 14, 2022 |
| Days to Decision | 283 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EMX - Balloon, Epistaxis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4100 |