FDA Product Code HEX: Colposcope (and Colpomicroscope)

510(k) Submission Activity

56 total 510(k) submissions under product code HEX since 1976, with 56 receiving FDA clearance (average review time: 153 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 HEX have taken an average of 263 days to reach a decision - up from 151 days historically. Manufacturers should account for longer review timelines in current project planning.