medical Class II Updated 2020-11-25

Micro-Tech Usa recalls Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots M190808231 M191018231 M191224231 M200305232
View official government recall

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