FDA Product Code PGZ: Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
To Control Bleeding In Junctional, Non-compressible Wounds Until Surgical Care Is Acquired.
Leading manufacturers include Revmedx, Inc..
FDA 510(k) Cleared Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use Devices (Product Code PGZ)
About Product Code PGZ - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PGZ since 2014, with 6 receiving FDA clearance (average review time: 151 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PGZ have taken an average of 44 days to reach a decision - down from 169 days historically, suggesting improved FDA processing for this classification.
PGZ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →