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510(k) Data Aggregation
K Number
K150068Device Name
Unimicro Veress Needle
Manufacturer
Unimicro Medical Systems (ShenZhen) Co.,Ltd.
Date Cleared
2015-07-31
(199 days)
Product Code
HIF, FHO
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Unimicro Medical Systems (ShenZhen) Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unimicro Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Device Description
The Unimicro Veress Needle is a sterile and single-use product. It incorporates a spring-loaded blunt stylet mechanism. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Unimicro Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
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