FDA Product Code KGW: Ring (wound Protector), Drape Retention, Internal
Leading manufacturers include Applied Medical Resources Corporation.
FDA 510(k) Cleared Ring (wound Protector), Drape Retention, Internal Devices (Product Code KGW)
About Product Code KGW - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code KGW since 1979, with 9 receiving FDA clearance (average review time: 114 days).
Submission volume has increased in recent years - 2 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 KGW have taken an average of 66 days to reach a decision - down from 128 days historically, suggesting improved FDA processing for this classification.
KGW devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →