K183190 is an FDA 510(k) clearance for the NuStat. This device is classified as a Temporary, Internal Use Hemostatic (Class II - Special Controls, product code POD).
Submitted by Beeken Biomedical, LLC (Stoughton, US). The FDA issued a Cleared decision on September 25, 2019, 310 days after receiving the submission on November 19, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4454. Intended To Control Severely Bleeding Wounds.
| 510(k) Number | K183190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2018 |
| Decision Date | September 25, 2019 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | POD - Temporary, Internal Use Hemostatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4454 |
| Definition | Intended To Control Severely Bleeding Wounds |