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U.S. Department of Health and Human Services

Product Classification

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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 CodePGZ
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)
Regulation Number 878.4452
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible