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510(k) Data Aggregation
K Number
K231407Device Name
StarFin
Manufacturer
Premium Medical Technology LLC
Date Cleared
2023-08-29
(106 days)
Product Code
HIF, GCJ
Regulation Number
884.1730Why did this record match?
Applicant Name (Manufacturer) :
Premium Medical Technology LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StarFin device is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperioneum for laparoscopic procedures prior to the placement of trocars. The StarFin device is also used for suture capture, externalization and internalization for wound closure after laparoscopic surgery.
Device Description
The subject device is a single-use, sterile, laparoscopic needle that is used for percutaneous introduction of a hollow stylet into the abdomen for gas insufflation and establishment of pneumoperitoneum prior to abdominal endoscopy and for closure of trocar site wounds with suture threads.
The subject device is equipped with a stainless steel cannular consisting of a beveled needle point for cutting through tissues. Inside the cannula, there is a spring-loaded inner stylet with a rounded blunt tip used for puncture protection. The hollow stainless steel inner stylet provides passing carbon dioxide gas to create pneumoperitoneum. The inner stylet tip is designed for suture capture, passing, externalization, and internalization for wound closure after laparoscopic surgery.
The environment of use is professional healthcare.
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