Recall Z-0470-2021— Micro-Tech Usa
Class II · Terminated
Class II FDA medical device recall by Micro-Tech Usa, initiated 2020-10-05, terminated 2021-12-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Micro-Tech Usa
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-05
- Terminated
- 2021-12-02
- Firm location
- Ann Arbor, MI, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.