🔍 RecallPedia

Micro-Tech Usa

1 recall •
🏥 Medical Devices
• Categories: Diagnostic Equipment

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.

Class I - Dangerous

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.

Oct 5, 2020 Diagnostic Equipment Nationwide View Details →