SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000

Insufflator, Laparoscopic

SURGIQUEST, INC.

The following data is part of a premarket notification filed by Surgiquest, Inc. with the FDA for Sugiquest Airsealoptical Trocar & Cannula System With Integrated Insufflator Dpis 2000.

Pre-market Notification Details

Device IDK103692
510k NumberK103692
Device Name:SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
ClassificationInsufflator, Laparoscopic
Applicant SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange,  CT  06477
ContactDaniel Donovan
CorrespondentDaniel Donovan
SURGIQUEST, INC. 12 CASCADE BLVD. SUITE 2B Orange,  CT  06477
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-17
Decision Date2011-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30653405988292 K103692 000

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