LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS Camera Head, Camera Coupler, Tablet Application

Laparoscope, General & Plastic Surgery

SMITH & NEPHEW

The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Lens Camera Control Unit-wifi, Lens Camera Unit-non-wifi, Lens Camera Head, Camera Coupler, Tablet Application.

Pre-market Notification Details

Device IDK153606
510k NumberK153606
Device Name:LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS Camera Head, Camera Coupler, Tablet Application
ClassificationLaparoscope, General & Plastic Surgery
Applicant SMITH & NEPHEW 150 MINUTEMAN ROAD Andover,  MA  01810
ContactJanice Haselton
CorrespondentJanice Haselton
SMITH & NEPHEW 150 MINUTEMAN ROAD Andover,  MA  01810
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-17
Decision Date2016-06-02
Summary:summary

NIH GUDID Devices

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