AEON Endoscopic Stapler

Staple, Implantable

Lexington Medical Inc.

The following data is part of a premarket notification filed by Lexington Medical Inc. with the FDA for Aeon Endoscopic Stapler.

Pre-market Notification Details

Device IDK201882
510k NumberK201882
Device Name:AEON Endoscopic Stapler
ClassificationStaple, Implantable
Applicant Lexington Medical Inc. 11 Executive Park Drive Billerica,  MA  01862
ContactRainer Maas
CorrespondentRainer Maas
Lexington Medical Inc. 11 Executive Park Drive Billerica,  MA  01862
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-08
Decision Date2020-10-09

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