HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit— 510(k) K162582

Substantially Equivalent

Fisher & Paykel Healthcare

FDA 510(k) clearance K162582 for HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit, Substantially Equivalent on 2017-06-23. Applicant: Fisher & Paykel Healthcare.

Clearance details

Applicant: Fisher & Paykel Healthcare
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-15
Decision date: 2017-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.