K122494 is an FDA 510(k) clearance for the POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT. This device is classified as a Splint, Intranasal Septal (Class I - General Controls, product code LYA).
Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on March 27, 2013, 223 days after receiving the submission on August 16, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4780.
| 510(k) Number | K122494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2012 |
| Decision Date | March 27, 2013 |
| Days to Decision | 223 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 |