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510(k) K222354

Elastic Traction System by Micro-Tech (Nanjing) Co., Ltd. — Product Code QSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2022
Date Received
August 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Traction Device
Device Class
Class II
Regulation Number
876.4410
Review Panel
GU
Submission Type

An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal.

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