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510(k) Data Aggregation
K Number
K151822Device Name
ab medica irrigation/suction gravity system
Manufacturer
Date Cleared
2015-09-04
(60 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
AB MEDICA S.A.S.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ab medica Irrigation/Suction Gravity System is indicated for use in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Device Description
ab medica Irrigation/Suction Gravity System is intended for irrigation and suctioning of the surgical field during laparoscopic surgery. This device is intended to be used in the operating room and by surgeons only. The system consists of control handpiece pre-connected to a tubing set and removable cannula. The tubing set and the 5 mm and 10 mm cannulae are single-use devices and provided in sterile condition. Only the 3 mm reusable cannula is provided non sterile. The system is used during laparoscopic surgery to deliver sterile irrigation fluids and/or to produce suction to evacuate blood and small tissue debris, and t o maintain a clear view of the surgical site. Irrigation and suctioning functions are provided through the cannula, which is inserted to the surgical site by means of a trocar, and are manually controlled by surgeon through the control valves on the handpiece.
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