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510(k) Data Aggregation
K Number
K022979Device Name
LAPARETTE, MODEL LAP J L S H N
Manufacturer
INSTRUMENTS MEDICAUX G.B., INC.
Date Cleared
2002-12-18
(100 days)
Product Code
KNF
Regulation Number
884.4160Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTS MEDICAUX G.B., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LAPARETTE is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of high-frequency electrical current, irrigate tissue and cavities, as well as suction fluids from the wound. This device is not intended for use in tubal sterilisation procedures.
Device Description
The LAPARETTE is a hybrid device consisting of three reusable component (Protective sheath, Electrode-Cannula, and Insulated Sleeve) and one single use component(Cartridge and Handle all together). All LAPARETTE components are supplied non sterile, requiring sterilization by health care facility before first use and reuse of the reusable components. The LAPARETTE is sold as a set. The only option possible for the customer is the form of the cautery tip.
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K Number
K010220Device Name
XTRACTOR, MODEL M143
Manufacturer
INSTRUMENTS MEDICAUX G.B., INC.
Date Cleared
2001-04-09
(75 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
INSTRUMENTS MEDICAUX G.B., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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