FDA Product Code HEW: Culdoscope (and Accessories)
Leading manufacturers include Applied Medical Resources Corp..
FDA 510(k) Cleared Culdoscope (and Accessories) Devices (Product Code HEW)
About Product Code HEW - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code HEW since 1996, with 18 receiving FDA clearance (average review time: 196 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 HEW have taken an average of 367 days to reach a decision - up from 186 days historically. Manufacturers should account for longer review timelines in current project planning.
HEW devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →