TissueTak Device

Staple, Implantable

Via Surgical Ltd.

The following data is part of a premarket notification filed by Via Surgical Ltd. with the FDA for Tissuetak Device.

Pre-market Notification Details

Device IDK203117
510k NumberK203117
Device Name:TissueTak Device
ClassificationStaple, Implantable
Applicant Via Surgical Ltd. Mitzpe Kineret Street 22/1 Amirim,  IL 2011500
ContactOfek Levin
CorrespondentOrly Maor
Orly Maor 25A Sirkin Street Kfar Saba,  IL 4442156
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-16
Decision Date2021-01-07

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