AFS Medical Sterile Single-Use Access Port System

Laparoscopic Single Port Access Device

AFS Medical Co. Ltd.

The following data is part of a premarket notification filed by Afs Medical Co. Ltd. with the FDA for Afs Medical Sterile Single-use Access Port System.

Pre-market Notification Details

Device IDK202688
510k NumberK202688
Device Name:AFS Medical Sterile Single-Use Access Port System
ClassificationLaparoscopic Single Port Access Device
Applicant AFS Medical Co. Ltd. Na-131, Ezen Mecha Zone, 117 Hwanggeum-ro, Yangchon-eup, Gimpo-si Gyeonggi-do,  KR 10048
ContactMin Ah Kim
CorrespondentMichele Lucey
Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury,  NH  03255
Product CodeOTJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2021-10-14

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