FDAOctober 5, 2020device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

micro techmicromicro tech

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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