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 Northgate Technologies, Inc., KARL STORZ Endoscopy-America, Inc. and Lexion Medical, LLC.