TRIPORT, TRIPORT+, TRIPORT15, QUADPORT

Laparoscopic Single Port Access Device

ADVANCED SURGICAL CONCEPTS

The following data is part of a premarket notification filed by Advanced Surgical Concepts with the FDA for Triport, Triport+, Triport15, Quadport.

Pre-market Notification Details

Device IDK111407
510k NumberK111407
Device Name:TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
ClassificationLaparoscopic Single Port Access Device
Applicant ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeOTJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-19
Decision Date2012-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391530440097 K111407 000

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