Hominis Surgical System

Mountable Electromechanical Surgical System For Transluminal Approaches

Memic Innovative Surgery Ltd.

The following data is part of a De Novo classification by Memic Innovative Surgery Ltd. with the FDA for Hominis Surgical System.

Pre-market Notification Details

DeNovo IDDEN190022
Device Name:Hominis Surgical System
ClassificationMountable Electromechanical Surgical System For Transluminal Approaches
Applicant Memic Innovative Surgery Ltd. 6 Yonatan Netanyahu Street Or Yehuda,  IL 6037604
ContactEinav Yemini
Product CodeQNM  
CFR Regulation Number878.4961 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypeDirect
Date Received2019-04-17
Decision Date2021-02-26
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
27290018151154 DEN190022 000
07290018151174 DEN190022 000
17290018151164 DEN190022 000
17290018151140 DEN190022 000
17290018151133 DEN190022 000
17290018151126 DEN190022 000
17290018151119 DEN190022 000
07290018151051 DEN190022 000
07290018151044 DEN190022 000
17290018151034 DEN190022 000
17290018151188 DEN190022 000
07290018151198 DEN190022 000
27290018151109 DEN190022 000
17290018151263 DEN190022 000
17290018151096 DEN190022 000
17290018151027 DEN190022 000
17290018151249 DEN190022 000
17290018151232 DEN190022 000
07290018151228 DEN190022 000
17290018151218 DEN190022 000
17290018151201 DEN190022 000
07290018151013 DEN190022 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.