CORE E3 Suction/irrigator

Laparoscope, General & Plastic Surgery

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Core E3 Suction/irrigator.

Pre-market Notification Details

Device IDK202303
510k NumberK202303
Device Name:CORE E3 Suction/irrigator
ClassificationLaparoscope, General & Plastic Surgery
Applicant ConMed Corporation 525 French Road Utica,  NY  13502
ContactTina Mornak
CorrespondentTina Mornak
ConMed Corporation 525 French Road Utica,  NY  13502
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-14
Decision Date2021-02-19

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