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FDA 510(k)

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

K-Number: K162582 · 2017-06-23

ApplicantFisher & Paykel Healthcare
Decision Date2017-06-23
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit is a medical device manufactured by Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2017-06-23 under approval number K162582. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit?

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Fisher & Paykel Healthcare. The 510(k) number is K162582.

When was HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit approved by the FDA?

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit received FDA 510(k) clearance on 2017-06-23, under approval number K162582.

What company makes HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit?

HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit is manufactured by Fisher & Paykel Healthcare.

What is the FDA product code for HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit?

The FDA product code for HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit is HIF.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Fisher & Paykel Healthcare

K162553AirSpiral Heated Breathing Tube K220703F&P 950 Respiratory Humidifier K221338F&P Airvo 3 K222292F&P myAirvo 3

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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