FDA-Device2020-11-25Class II
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.
Micro-Tech Usa
Hazard
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.
Sold states
US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.
Affected count
2420 pieces
Manufactured in
2855 Boardwalk St, N/A, Ann Arbor, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2021Don't want to check this manually?
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