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510(k) Data Aggregation
K Number
K030422Device Name
LINA-BAG, MODELS LB-60, LB-100
Manufacturer
LINA MEDICAL CML APS
Date Cleared
2003-04-14
(63 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
LINA MEDICAL CML APS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient without contamination during laparoscopic surgery such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, fibroid tumors, small sections of bowel and other tissue structures.
Device Description
The LiNA-Bag is a laparoscopic instrument consisting of a collapsible pouch attached and placed within a long slender multi-part tube allowing for introduction of said pouch through a laparoscopic trocar. Opening and closing of the pouch is activated by manual manipulation in a push and pull motion of the attached tube that has a corresponding nylon drawstring attached to the pouch.
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