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510(k) K201744

Su2ura Approximation Device by Anchora Medical, Ltd. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2021
Date Received
June 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Tissue Approximation Device
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

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