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510(k) K201035

ETHICON Linx Esophagus Sizing Tool by Torax Medical, Inc. — Product Code QJN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 9, 2020
Date Received: April 20, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laparoscopic Accessories, Esophageal Sizing
Device Class: Class II
Regulation Number: 876.5360
Review Panel: GU
Submission Type

To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.