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510(k) K172666

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor by Sutureease, Inc. — Product Code OCW

K172666 is an FDA 510(k) premarket notification submitted by Sutureease, Inc. for the device "CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor". The FDA issued a decision of Substantially Equivalent on December 1, 2017. 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
December 1, 2017
Date Received
September 5, 2017
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