MODIFIED SURGIQUEST AIRSEAL OPTICAL 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 Modified Surgiquest Airseal Optical Trocar & Cannula System With Integrated Insufflator Dpis 2000.

Pre-market Notification Details

Device IDK121336
510k NumberK121336
Device Name:MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
ClassificationInsufflator, Laparoscopic
Applicant SURGIQUEST, INC. 333 Quarry Rd Milford,  CT  06460
ContactDaniel Donovan
CorrespondentDaniel Donovan
SURGIQUEST, INC. 333 Quarry Rd Milford,  CT  06460
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-03
Decision Date2012-07-03
Summary:summary

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