Tenex Receives FDA Clearance for TX2 MicroTip to Treat Chronic Tendinosis

By Julie A. Vetalice

Tenex Health received FDA 510(k) clearance to market the TX2 MicroTip, with application to treat tendinosis of the shoulder and hip in an outpatient procedure. Launch is slated for mid-2016.

The TX2 MicroTip, a disposable ultrasonic energy instrument that cuts and removes targeted soft tissue, builds on the company's initially-cleared TX1 Tissue Removal System in that its extended length will support percutaneous tenotomy in regions of the body not accessible by the shorter TX1 instrument.

Source: Tenex Health, Inc.

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory