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510(k) Data Aggregation
K Number
K020526Device Name
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
Manufacturer
DON WILSON/WILSON-COOK MEDICAL, INC.
Date Cleared
2002-03-19
(28 days)
Product Code
FHN
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
DON WILSON/WILSON-COOK MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to ligate internal hemorrhoids.
Device Description
The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only. The modification of the predicate Wilson-Cook Multiple Band Ligator (K944220/A) consists of a change to the handle in order to accommodate single-hand operation through an anoscope. In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the modified Multiple Band Ligator is used in conjunction with an anoscope. The barrel and bands of the modified device are identical to the barrel and bands of the Wilson-Cook Multiple Band Ligator in the choice of the production and the specifications of each. The trigger cord is comprised of the same materials, however the trigger cord is slightly shorter in length for the modified devices, as the modified device comes preloaded and is used with an anoscope. Loading catheter and irrigation adapter are not needed.
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