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510(k) Data Aggregation
K Number
K102581Device Name
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
Manufacturer
BYRNE MEDICAL INC.
Date Cleared
2010-11-08
(61 days)
Product Code
ODC, FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BYRNE MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Device Description
The DEFENDO™ Disposable Suction Valve is a disposable device that attaches to the suction cylinder of an endoscope. When the valve is depressed, the suction function on the endoscope is activated, allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.
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K Number
K102409Device Name
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
Manufacturer
BYRNE MEDICAL INC.
Date Cleared
2010-11-04
(72 days)
Product Code
ODC, FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BYRNE MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEFENDO™ Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
Device Description
The Byrne Medical DEFENDO™ Disposable Air/Water Valve is substantially equivalent to the Olympus® MH-438 Air/Water Valve.
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K Number
K093665Device Name
ENDO SMARTCAP
Manufacturer
BYRNE MEDICAL INC.
Date Cleared
2009-12-15
(20 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BYRNE MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Device Description
Not Found
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K Number
K092090Device Name
ERBELIFT HAND PUMP AND FLEXIBLE PROBE
Manufacturer
BYRNE MEDICAL INC.
Date Cleared
2009-11-30
(139 days)
Product Code
FBK
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BYRNE MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ERBELIFT Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.
Device Description
The ERBELIFT™ Hand Pump and Flexible Probe are used for the delivery of pressurized sterile normal saline to the submucosa to lift polyps or other mucosal lesions. A control syringe is filled with sterile normal saline. The filled syringe is attached to the Flexible Probe via a hub with a standard luer lock and loaded into the Hand Pump. The Flexible Probe is primed with the saline and then the distal end of the Probe is placed down the working channel of the endoscope. Under direct visualization, the Probe's tip is placed against the target tissue without puncturing the mucosa. Then, the trigger of the Hand Pump is squeezed to produce the pressurized saline from the control syringe and through the Probe into the bed of the polyp or lesion to achieve a desired tissue lift.
The Hand Pump is made of nylon and stainless steel. It is 8-3/4" (22 cm) long, 6" (15 cm) wide, and having a thickness of 2-1/2" (6 cm). The Pump per squeeze of the handle delivers approximately 0.75 ml of normal saline. The Flexible Probe is made of Polyetheretherketone (PEEK) and nylon (Note: Medical grade inks and reducer are used to imprint logos on the device.). It has a 1.3 mm Outer Diameter and length of 260 cm. The distal tip is tapered to approximately 0.005" and delivers a jet stream of 120 um. The Hand Pump with the Flexible Probe can generate pressures in the approximate range of 145 to 650 psi which correlates to flow rates of 17 to 38 ml/minute.
The Hand Pump is reusable with the Flexible Probe being provided as sterile and single use.
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K Number
K090851Device Name
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
Manufacturer
BYRNE MEDICAL INC.
Date Cleared
2009-07-02
(94 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BYRNE MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEFENDO™ Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
Device Description
Not Found
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