Definition: Intended To Control Severely Bleeding Wounds
| Device Type ID | 5873 |
| Device Name | Temporary, Internal Use Hemostatic |
| Physical State | Hemostatic Agent Either Alone Or Incorporated Into/onto Another Material, E.g. Gauze. |
| Technical Method | Proposed Hemostatic Mechanisms Of Action Include Physical Tamponade, Water Absorption, And Mechanical Sealing. |
| Target Area | Indicated For Use For Severely Bleeding Wounds Such As Surgical Wounds And Traumatic Injuries, Including Organ Space Bleeding. |
| Regulation Description | Non-absorbable, Hemostatic Gauze For Temporary Internal Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4454 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5873 |
| Device | Temporary, Internal Use Hemostatic |
| Product Code | POD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Non-absorbable, Hemostatic Gauze For Temporary Internal Use. |
| CFR Regulation Number | 878.4454 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
Z-MEDICA, LLC | ||
GRANTED | 1 | |