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510(k) Data Aggregation
K Number
K973068Device Name
KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
Manufacturer
Date Cleared
1997-11-07
(81 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ ENDOSKOP GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is intended for endoscopic saphenous vein harvesting procedures.
These instruments are manually operated surgical devices intended to be used in procedures for removal of the saphenous vein as a graft in coronary and vascular surgery.
Device Description
The Karl Storz Instrument Set for Endoscopic Saphenous Vein Harvesting are manually operated surgical devices. The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is composed of Forward Oblique (30°) Endoscope, Optical Retractor and Optical Dissector, Vein Dissectors, Grasping Forceps, Dissecting and Grasping Forceps, and Hook Scissors, Take-apart™ Dissecting Forceps, Dissecting and Grasping Forceps, and Scissors, Take-apart® Bipolar Forceps, and Suction Coagulating Cannula. The body contact portions of the KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting are composed of surgical grade stainless steel, PTFE, Kynar and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
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K Number
K961702Device Name
KSEA VAPORIZATION ELECTRODES
Manufacturer
Date Cleared
1996-08-29
(119 days)
Product Code
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ ENDOSKOP GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).
Device Description
The KSEA vaporization electrodes are manually operated, singleuse instruments which are provided sterile to the end-user. The instruments are long enough to gain access to the surgical area, and are designed to be used as accessories to resectoscopes. The body contact materials have a long history of use in medical devices, and do not pose any new issues of safety and effectiveness.
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