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510(k) Data Aggregation
K Number
K080161Device Name
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR
Manufacturer
Date Cleared
2008-05-29
(127 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PATTON SURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PassPort® Optical Trocar is an access device that may be used with or without visualization that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Vortex Seal functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Blunt Tip Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Shielded Trocar is an access device that creates and maintains a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
The PassPort® Cannula Anchor functions in combination with Patton Surgical's PassPort® Trocar to create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures such as general, gynecologic, thoracic, and urological procedures.
Device Description
The Candidate Devices are a single patient device to be utilized as an access port.
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K Number
K052907Device Name
POLARCOAT
Manufacturer
Date Cleared
2006-10-16
(367 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PATTON SURGICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Patton Surgical PolarCoat is a single patient use device which is intended for use on electrodes to reduce sticking.
Device Description
The Candidate Device is a yellow-brown substance, Lecithin with soy protein removed. The Candidate Device is a single patient device, available on sponge or in bottle, to be used on electrodes to reduce sticking. The Candidate Device is sterilized by the Irradiation method and packaged individually within a shipper container of 20 units per container.
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