Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2021