YelloPort Elite Port Access System

Laparoscope, General & Plastic Surgery

Surgical Innovations Limited

The following data is part of a premarket notification filed by Surgical Innovations Limited with the FDA for Yelloport Elite Port Access System.

Pre-market Notification Details

Device IDK190592
510k NumberK190592
Device Name:YelloPort Elite Port Access System
ClassificationLaparoscope, General & Plastic Surgery
Applicant Surgical Innovations Limited Clayton Wood House 6 Clayton Wood Bank Leeds,  GB Ls16 6qz
ContactShazia Chaudhry
CorrespondentShazia Chaudhry
Surgical Innovations Limited Clayton Wood House 6 Clayton Wood Bank Leeds,  GB Ls16 6qz
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-07
Decision Date2019-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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05051986002088 K190592 000

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