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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K162582
Device Name HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
Applicant
Fisher & Paykel Healthcare
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Applicant Contact Tina O'Brien
Correspondent
Fisher & Paykel Healthcare
15 Maurice Paykel Pl., E. Tamaki
Auckland,  NZ 2013
Correspondent Contact Nicole Senasac
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/15/2016
Decision Date 06/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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