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)
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 |