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 510(k) Review Time - KGW Product Code

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 →

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Apr 24, 2026

Product Code Info

Code	KGW
Device class	Class II
CFR	21 CFR 878.4370
Panel	General & Plastic Surgery

Verify on FDA.gov

View KGW classification on FDA.gov →