Search Results
Found 9 results
510(k) Data Aggregation
K Number
K250573Device Name
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
Manufacturer
Olympus Medical Systems Corp.
Date Cleared
2025-05-27
(90 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.
The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.
Device Description
The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series is comprised of nine (9) sterile, single-use, cannulas designed to inject contrast medium in the biliary or pancreatic duct when used in conjunction with a compatible endoscope.
Each device has two sections: the handle (proximal portion) and the insertion portion. The insertion portion is introduced into the biliary or pancreatic ducts through an endoscope. The distal end of the insertion portion is designed for smooth cannulation of the papilla of Vater or the minor papilla. All models are visible under fluoroscopy and feature a distal marking system.
The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series models are to be used with compatible endoscopes.
Ask a Question
K Number
K202583Device Name
BioShield biopsy valve EUS - Linear
Manufacturer
Steris Corporation
Date Cleared
2020-11-06
(59 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The single use BioShield® biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.
Device Description
The BioShield® biopsy valve EUS - Linear is an accessory to a linear echoendoscope. The EUS biopsy valve allows the end user to cover the accessory port of a linear echoendoscope. The BioShield® biopsy valve EUS - Linear consists of tether and cap. The biopsy valves' cap can be removed from the accessory port while being held on the echoendoscope via the tether to the cap. The biopsy valve is a single-use, disposable device that is supplied sterile or nonsterile.
Ask a Question
K Number
K171989Device Name
Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
Manufacturer
Wilson-Cook Medical Inc.
Date Cleared
2018-03-20
(260 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.
Device Description
The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip.
The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.
Ask a Question
K Number
K070420Device Name
BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
2007-03-19
(27 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The single use BioShield® - ERCP biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
Device Description
Not Found
Ask a Question
K Number
K011149Device Name
DISPOSABLE BENDING CANNULA PR-233Q
Manufacturer
THE OLYMPUS OPTICAL CO.
Date Cleared
2001-05-15
(29 days)
Product Code
ODD, FGE
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This instrument has been designed to be used with an Olympus endoscope I mis instrument mas count in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.
Device Description
The subject device is a cannula which has a bending function (angle wire), to be used in accordance with Intended Use of the Device. This bending function enables the subject device to be manipulated in 2 directions and leads to easier insertion into the biliary and pancreatic ducts.
Ask a Question
K Number
K010993Device Name
ALIEN RX MICRO CANNULA, MODEL 4530
Manufacturer
BOSTON SCIENTIFIC CORP.
Date Cleared
2001-04-30
(27 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alien™ RX Micro Cannula is indicated for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram.
Device Description
The proposed Alien™ RX Micro Cannula is a single lumen cannula. It is compatible with the Boston Scientific Microvasive Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .025" guidewire while passing through a .035" lumen.
Ask a Question
K Number
K973205Device Name
WILSON-COOK STRICTURE MEASURING CATHETER
Manufacturer
WILSON-COOK MEDICAL, INC.
Date Cleared
1997-11-24
(90 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wilson-Cook Stricture Measuring Catheter is used to measure biliary and pancreatic strictures to determine stent size. This catheter allows injection of contrast and provides wire guide access to the desired duct. This device is supplied sterile and is intended for single use only.
Device Description
The Wilson-Cook Stricture Measuring Catheter consists of a stylet wire and catheter. This device is designed for injection of contrast and to measure biliary and pancreatic strictures to determine stent size. This device is supplied sterile and is intended for single use only.
Ask a Question
K Number
K963051Device Name
ERCP CANNULA
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
1997-03-28
(234 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.
Device Description
The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage.
Ask a Question
K Number
K953967Device Name
ENDOSCOPIC CATHETER
Manufacturer
ACT MEDICAL, INC.
Date Cleared
1996-01-22
(153 days)
Product Code
ODD
Regulation Number
876.1500Why did this record match?
Product Code :
ODD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1