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, Scivita Medical Technology Co., Ltd. and Freyja Healthcare, LLC.
FDA 510(k) Cleared Insufflator, Laparoscopic Devices (Product Code HIF)
About Product Code HIF - Regulatory Context
510(k) Submission Activity
177 total 510(k) submissions under product code HIF since 1978, with 177 receiving FDA clearance (average review time: 191 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
Recent submissions under HIF have taken an average of 162 days to reach a decision - down from 192 days historically, suggesting improved FDA processing for this classification.
HIF devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →