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Found 3 results
510(k) Data Aggregation
K Number
K021747Device Name
DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
Manufacturer
SURGICON, INC.
Date Cleared
2002-08-15
(79 days)
Product Code
GCI
Regulation Number
876.1500Why did this record match?
Product Code :
GCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.
Device Description
The device consists of an introducer and a polyurethane specimen container into which the excised gallbladder is placed. The device, with the specimen held within, is then withdrawn through the abdominal access wound (previously created by the trocar). The device can operate through a variety of access port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.
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K Number
K003222Device Name
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
Manufacturer
COMPUTER MOTION, INC.
Date Cleared
2000-11-03
(18 days)
Product Code
GCI
Regulation Number
876.1500Why did this record match?
Product Code :
GCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001362Device Name
KARL STORZ 3D VIDEO SYSTEM
Manufacturer
KARL STORZ IMAGING, INC.
Date Cleared
2000-07-17
(80 days)
Product Code
GCI
Regulation Number
876.1500Why did this record match?
Product Code :
GCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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