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510(k) Data Aggregation
K Number
K131402Device Name
VISICLEAR SMOKE EVACUATION SYSTEM
Manufacturer
BUFFALO FILTER CO., INC.
Date Cleared
2014-03-03
(292 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
BUFFALO FILTER CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VISICLEAR Smoke Evacuation System is designed to remove and filter smoke, aerosols produced during electrosurgical and laser procedures.
Indications for use for the VISICLEAR smoke evacuation system include:
a. To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures
Device Description
The VISICLEAR smoke evacuation system is a self-contained system that is used to remove and filter surgical smoke. The device is intended for general electrosurgical and laser applications for removing smoke generated by electrosurgery and laser procedures.
The device is constructed using the same materials and design specifications commonly found in the predicate devices in the smoke evacuation marketplace. The smoke evacuator is comprised of a vacuum motor, aluminum, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the smoke from the surgical site, through the vacuum tubing and into the VISICLEAR filter where the surgical smoke is processed by a series of filtration stages.
The vacuum flow rate for the VISICLEAR smoke evacuation device ranges from a minimum of 5 liters per minute (LPM) in Laparoscopic Mode to 30 cubic feet per minute in Open Mode. These flow rates are substantially equivalent to the flow range for the predicate devices.
The filter for the VISICLEAR smoke evacuation system, like the filters for the predicate devices, is a replaceable self-contained filter that is completely enclosed to protect health care personnel from potential contamination during filter changes. The VIROSAFE 135 filter ("VS135") is an Ultra Low Penetration Air (ULPA) grade with carbon fitter that has filter efficiency of 99.999% for particle sizes of 0.1 to 0.2 microns or greater. These characteristics are consistent with the predicate devices.
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K Number
K000904Device Name
PENADAPT 10
Manufacturer
BUFFALO FILTER CO., INC.
Date Cleared
2000-06-08
(79 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
BUFFALO FILTER CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983298Device Name
BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
Manufacturer
BUFFALO FILTER CO., INC.
Date Cleared
1999-08-16
(329 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
BUFFALO FILTER CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indications for Use of the ViroSafe EY Filter and Buffalo Filter® EY Prefilter are for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, or other smoke plume producing devices. This device is not intended for contact with the patient, It is intended to be used during either open or endoscopic surgical procedures.
Device Description
Disposable Smoke Evacuation Filter
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K Number
K983333Device Name
BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
Manufacturer
BUFFALO FILTER CO., INC.
Date Cleared
1999-08-11
(322 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
BUFFALO FILTER CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indications for Use of the ViroSafe® ODR Filter is for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.
Device Description
Not Found
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K Number
K983364Device Name
BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
Manufacturer
BUFFALO FILTER CO., INC.
Date Cleared
1999-08-11
(321 days)
Product Code
FYD
Regulation Number
878.5070Why did this record match?
Applicant Name (Manufacturer) :
BUFFALO FILTER CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indications for Use of the ViroSafe® 18 Filter is for the removal and filtration of the smoke and incidental fluid produced during electrosurgery, laser surgery, or other smoke plume producing devices. This device is not intended for contact with the patient. It is intended to be used during either open or endoscopic surgical procedures.
Device Description
Disposable Smoke Evacuation Filter
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