ETHICON Linx Esophagus Sizing Tool— 510(k) K201035

Name: FDA 510(k) clearance K201035
Creator: U.S. Food and Drug Administration
Published: 2020-07-09

Substantially Equivalent

Torax Medical, Inc.

FDA 510(k) clearance K201035 for ETHICON Linx Esophagus Sizing Tool, Substantially Equivalent on 2020-07-09. Applicant: Torax Medical, Inc.. Device class: 2.

Clearance details

Applicant: Torax Medical, Inc.
Product code: Code QJN
Device class: Class 2
Regulation: 21 CFR 876.5360
Advisory panel: Gastroenterology, Urology
Date received: 2020-04-20
Decision date: 2020-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreview, MN, US

Download summary PDF View on FDA.gov ↗

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