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510(k) Data Aggregation
K Number
K142068Device Name
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE
Manufacturer
MEDOVATIONS, INC.
Date Cleared
2015-03-10
(223 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The single use BullDog® Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® 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
The Medovations Disposable Biopsy Valve is a single piece construction of molded thermoplastic elastomer. The biopsy valve has a cylindrical body with an open inner diameter for device passage. This cylindrical body has a connected cap with a slit to allow for endoscopic device passage and exchange, to help maintain sufflation, to minimize leakage of biomaterial from the biopsy port throughout endoscopic procedures, and to provide access for irrigation. The distal part of the biopsy valve body is molded to fit the biopsy/suction channel of the endoscope. The proximal part of the biopsy valve body is molded to fit around the cap when it is in the closed position. The Medovations Disposable Biopsy Valves are manufactured in two configurations one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. The Olympus®/Fujinon® versions are sold as both sterile and non-sterile devices. The Pentax® version is sold non-sterile. The Irrigating Adaptor accessory is comprised of a metal tube with standard luer lock and can be used with the biopsy valve to provide access for irrigation.
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K Number
K002363Device Name
MEDOVATIONS ESOPHAGEAL DILATOR
Manufacturer
MEDOVATIONS, INC.
Date Cleared
2000-11-01
(90 days)
Product Code
KNQ
Regulation Number
876.5365Why did this record match?
Applicant Name (Manufacturer) :
MEDOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K972119Device Name
MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
Manufacturer
MEDOVATIONS, INC.
Date Cleared
1998-02-02
(242 days)
Product Code
FAT
Regulation Number
876.5365Why did this record match?
Applicant Name (Manufacturer) :
MEDOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Maloney and Hurst Bougies indications for use are for the dilation of: 1 - Upper esophageal webs. 2 - Lower esophageal rings. 3 - Caustic strictures. 4 - Peptic esophageal strictures. 5 - Temporary ease of esophageal carcinoma.
Device Description
Not Found
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