Definition: To Control Bleeding In Junctional, Non-compressible Wounds Until Surgical Care Is Acquired.
| Device Type ID | 5863 |
| Device Name | Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use |
| Physical State | Sterile, Non-absorbable, Radiopaque, Expandable Sponges That May Include A Delivery Device. |
| Technical Method | The Sponges Expand Upon Contact With Blood To Fill The Wound Cavity And Provide Pressure And A Physical Barrier That Facilitates Formation Of A Clot. The Temporary Sponges Are Completely Removed From The Wound During Surgery Prior To Closure. |
| Target Area | Junctional, Non-compressible Wounds In The Groin Or Axilla Not Amenable To Tourniquet Application. It Is NOT Indicated For Use In The Following Areas: Thorax; Pleural Cavity; Mediastinum; Abdomen; Retroperitoneal Space; Sacral Space Above The Inguina |
| Regulation Description | Nonabsorbable Expandable Hemostatic Sponge 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 | 878.4452 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5863 |
| Device | Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use |
| Product Code | PGZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonabsorbable Expandable Hemostatic Sponge For Temporary Internal Use. |
| CFR Regulation Number | 878.4452 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
REVMEDX, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 4 | |