ETHICON Linx Esophagus Sizing Tool

Laparoscopic Accessories, Esophageal Sizing

Torax Medical, Inc.

The following data is part of a premarket notification filed by Torax Medical, Inc. with the FDA for Ethicon Linx Esophagus Sizing Tool.

Pre-market Notification Details

Device IDK201035
510k NumberK201035
Device Name:ETHICON Linx Esophagus Sizing Tool
ClassificationLaparoscopic Accessories, Esophageal Sizing
Applicant Torax Medical, Inc. 4188 Lexington Avenue, N Shoreview,  MN  55126
ContactJoseph Ciccone
CorrespondentJoseph Ciccone
Torax Medical, Inc. 4188 Lexington Avenue, N Shoreview,  MN  55126
Product CodeQJN  
CFR Regulation Number876.5360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2020-07-09

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