FDA Product Code HET: Laparoscope, Gynecologic (and Accessories)
Leading manufacturers include Olympus Medical Systems Corp., A.M.I. Agency For Medical Innovations GmbH and Precision Robotics (Hong Kong) Limited.
FDA 510(k) Cleared Laparoscope, Gynecologic (and Accessories) Devices (Product Code HET)
About Product Code HET - Regulatory Context
510(k) Submission Activity
338 total 510(k) submissions under product code HET since 1977, with 338 receiving FDA clearance (average review time: 205 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HET have taken an average of 144 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.
HET devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →