Temporary, Internal Use Hemostatic
FDA product code POD · Class II (moderate risk) · 21 CFR 878.4454 · General, Plastic Surgery
Intended to control severely bleeding wounds
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243553 | QuikClot Control+ Hemostatic DevicePOD · Traditional | Teleflex Medical | 03/18/2025SE |
| K213198 | Ax-Surgi Surgical HemostatPOD · Traditional | Advamedica, Inc. | 01/05/2023SE |
| K220971 | QuikClot Control+ Hemostatic DressingPOD · Traditional | Z-Medica, LLC | 12/14/2022SE |
| K200167 | QuikClot Control+POD · Traditional | Z-Medica, LLC | 04/23/2020SE |
| K183190 | NuStatPOD · Traditional | Beeken Biomedical, LLC | 09/25/2019SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0309-2022 Class II | NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ…Endotoxin levels exceeded allowable limits. | Beeken Biomedical, LLC | 10/14/2021Open, Classified |