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510(k) K230089

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 9, 2023
Date Received: January 12, 2023
Clearance Type: Special
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.