FDA Product Code HIF: Insufflator, Laparoscopic
FDA product code HIF covers laparoscopic insufflators used to create and maintain the pneumoperitoneum during minimally invasive surgery.
These devices deliver carbon dioxide gas at controlled flow rates and pressures to distend the abdomen, creating the working space needed for laparoscopic instruments and visualization. Precise pressure control prevents complications related to excessive insufflation pressure.
HIF devices are Class II medical devices, regulated under 21 CFR 884.1730 and reviewed by the FDA Obstetrics & Gynecology panel.
Leading manufacturers include Conmed Corporation, Olympus Medical Systems Corporation and Karl Storz SE & CO. KG.
List of Insufflator, Laparoscopic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Insufflator, Laparoscopic devices (product code HIF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Obstetrics & Gynecology FDA review panel. Browse all Obstetrics & Gynecology devices →