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510(k) K160149

Miret Grasper, Alligator, Miret Grasper, Maryland by Miret Surgical, Inc. — Product Code OCW

K160149 is an FDA 510(k) premarket notification submitted by Miret Surgical, Inc. for the device "Miret Grasper, Alligator, Miret Grasper, Maryland". The FDA issued a decision of Substantially Equivalent on August 30, 2016. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2016
Date Received
January 21, 2016
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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FDA data resources