SurgiQuest AIRSEAL IFS System

Insufflator, Laparoscopic

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Surgiquest Airseal Ifs System.

Pre-market Notification Details

Device IDK172516
510k NumberK172516
Device Name:SurgiQuest AIRSEAL IFS System
ClassificationInsufflator, Laparoscopic
Applicant ConMed Corporation 488 Wheelers Farms Road Milford,  CT  06461
ContactLisa Anderson
CorrespondentMichael Daniel
Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville,  NV  89460
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-21
Decision Date2018-03-16
Summary:summary

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