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 the device name listed in this FDA 510(k) record. The listed applicant is Torax Medical, Inc.. It received FDA 510(k) clearance on 2020-07-09 under 510(k) 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. The listed applicant is Torax Medical, Inc.. The 510(k) number is K201035.

When did ETHICON Linx Esophagus Sizing Tool receive FDA 510(k) clearance?

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

Who is the listed applicant for ETHICON Linx Esophagus Sizing Tool?

The FDA 510(k) record lists Torax Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Torax Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P100049IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX K230089ETHICON LINX® Esophagus Sizing Tool

Related Devices (Code: QJN)

K230089ETHICON LINX® Esophagus Sizing ToolTorax Medical, Inc.

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.