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510(k) K201035

Device
ETHICON Linx Esophagus Sizing Tool
Applicant
Torax Medical, Inc.
510(k) number
K201035
Product code
QJN  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-09
Date received
2020-04-20
Regulation
876.5360
Classification name
Laparoscopic Accessories, Esophageal Sizing
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joseph Ciccone
Address
4188 Lexington Ave., N Shoreview MN US 55126 55126

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QJN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230089ETHICON LINX® Esophagus Sizing ToolTorax Medical, Inc.2023-02-09

Legacy Summary#

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FDA Review#

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