FDA Product Code HIG: Insufflator, Hysteroscopic
Leading manufacturers include Hologic, Inc. and Boston Scientific Corporation.
FDA 510(k) Cleared Insufflator, Hysteroscopic Devices (Product Code HIG)
About Product Code HIG - Regulatory Context
510(k) Submission Activity
56 total 510(k) submissions under product code HIG since 1984, with 56 receiving FDA clearance (average review time: 249 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
FDA review times for HIG submissions have been consistent, averaging 226 days recently vs 250 days historically.
HIG devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →