Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ETHICON Linx Esophagus Sizing Tool

K-Number: K201035 · 2020-07-09

Decision Date2020-07-09
Product CodeQJN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ETHICON Linx Esophagus Sizing Tool is a medical device manufactured by Torax Medical, Inc.. It received FDA 510(k) clearance on 2020-07-09 under approval number K201035. The device is classified under product code QJN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHICON Linx Esophagus Sizing Tool?

ETHICON Linx Esophagus Sizing Tool is a medical device that received FDA 510(k) clearance on 2020-07-09. It is manufactured by Torax Medical, Inc.. The 510(k) number is K201035.

When was ETHICON Linx Esophagus Sizing Tool approved by the FDA?

ETHICON Linx Esophagus Sizing Tool received FDA 510(k) clearance on 2020-07-09, under approval number K201035.

What company makes ETHICON Linx Esophagus Sizing Tool?

ETHICON Linx Esophagus Sizing Tool is manufactured by Torax Medical, Inc..

What is the FDA product code for ETHICON Linx Esophagus Sizing Tool?

The FDA product code for ETHICON Linx Esophagus Sizing Tool is QJN.

Other Devices by Torax Medical, Inc.

Related Devices (Code: QJN)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.