FDA Product Code HIH: Hysteroscope (and Accessories)
Hysteroscopy enables direct visualization of the uterine cavity without laparotomy. FDA product code HIH covers hysteroscopes and their accessories.
These rigid or flexible endoscopes are inserted through the cervix to visualize the endometrium and uterine cavity for the diagnosis and treatment of abnormal uterine bleeding, polyps, fibroids, and intrauterine adhesions. Operative hysteroscopes include working channels for resection and ablation instruments.
HIH devices are Class II medical devices, regulated under 21 CFR 884.1690 and reviewed by the FDA Obstetrics & Gynecology panel.
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Guangzhou Red Pine Medical Instrument Co., Ltd. and Stryker Endoscopy.
FDA 510(k) Cleared Hysteroscope (and Accessories) Devices (Product Code HIH)
About Product Code HIH - Regulatory Context
510(k) Submission Activity
169 total 510(k) submissions under product code HIH since 1980, with 169 receiving FDA clearance (average review time: 168 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under HIH have taken an average of 104 days to reach a decision - down from 170 days historically, suggesting improved FDA processing for this classification.
HIH devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →