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 Hologic, Inc., KARL STORZ Endoscopy-America, Inc. and Smith & Nephew, Inc..