Clearance Summary
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit received FDA 510(k) clearance under submission number K162582, sponsored by Fisher & Paykel Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2017-06-23.
- Submission: K162582
- Applicant / Sponsor: Fisher & Paykel Healthcare
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2017-06-23
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.