ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE

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 Asc Triport+ Laparoscopic Access Device.

Pre-market Notification Details

Device IDK110004
510k NumberK110004
Device Name:ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
ClassificationLaparoscopic Single Port Access Device
Applicant ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington,  DC  20004
ContactJonathan Kahan
CorrespondentJonathan Kahan
ADVANCED SURGICAL CONCEPTS 355 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeOTJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-03
Decision Date2011-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391530440066 K110004 000

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