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Torax Medical, Inc.: FDA-registered device maker in Cincinnati, OH, United States, 2 510(k) clearances and 1 PMA approval

Name: Torax Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Torax Medical, Inc. is registered with the FDA (registration 3008766073) in Cincinnati, OH, United States. It lists 4 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated February 9, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3008766073
Address: 4545 Creek Road, Cincinnati, OH, United States, 45242
Owner or operator: Torax Medical Inc. (10040266)
Roles: Specification developer
First device listed: March 26, 2012
Registered through: 2026
Brand names listed: ETHICON LINX® Esophagus Sizing Tool, ETHICON Linx Esophagus Sizing Tool, FENIX Continence Restoration System, LINX Reflux Management System

Devices it lists

Device	Product code	Class	Role	Source
Implant, Anti-Gastroesophageal Reflux	LEI	3	Specification developer	accessdata.fda.gov
Implanted Fecal Incontinence Device	MIP	3	Specification developer	accessdata.fda.gov
Laparoscopic Accessories, Esophageal Sizing	QJN	2	Specification developer	accessdata.fda.gov
Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)	PMH	f	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 9, 2023	K230089	ETHICON LINX® Esophagus Sizing Tool	QJN	Substantially Equivalent	Torax Medical, Inc.	accessdata.fda.gov
July 9, 2020	K201035	ETHICON Linx Esophagus Sizing Tool	QJN	Substantially Equivalent	Torax Medical, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 22, 2012	P100049	LINX REFLUX MANAGEMENT SYSTEM	LEI	40	January 16, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 20, 2018	79822	Class II	Terminated	LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Co	Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.	accessdata.fda.gov

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Updated January 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.