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510(k) Data Aggregation
K Number
K172666Device Name
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
Manufacturer
Date Cleared
2017-12-01
(87 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SutureEase, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is intended to pass suture through soft tissue lavers (fascia, muscle and perioneum) of a trocar wound at the end of laparoscopic surgery.
It is to be used only by surgeons trained in endoscopic/laparoscopic surgery.
Device Description
The CrossBow Fascial Closure System is a set of single-use instruments primarily intended for the use of closing soft tissue layers (fascia, muscle and peritoneum) of a trocar wound following laparoscopic surgery. The CrossBow Fascial Closure System has two basic components: (1) a suture passer component used to pass suture through the abdominal wall, and (2) a guide used to repeatedly direct the needle through the abdominal wall using visual markers to reference the needle puncture location off the inner wall of the abdomen. The guide has two deployable snare loops used to secure and retrieve the free ends of suture passed by the suture passer. The device also has an accessory adaptor to accommodate larger size port defects.
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