| Device |
non-absorbable, expandable, hemostatic sponge for temporary internal use |
| Regulation Description |
Nonabsorbable expandable hemostatic sponge for temporary internal use. |
| Definition |
To control bleeding in junctional, non-compressible wounds until surgical care is acquired. |
| 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 inguinal ligament; or tissues above the clavicle. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PGZ |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4452
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
