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510(k) Data Aggregation
K Number
K960020Device Name
SOLO BAND LIGATOR
Manufacturer
Date Cleared
1996-04-01
(90 days)
Product Code
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
SURCRAFT LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The new device is therefor a socalled "combination" devise that claims to have the same intended uses as several different types of predicate devices
Device Description
The new device has incorporated features of the above tools into one device, resulting in one instrument that can bring into view and ligate hemorrhoids, all at the same time, by the operating surgeon. No assistant is needed. The tool is a double barreled tube, the internal tube carrying a preloaded latex elastic band slightly protuding from the external tube. An obturator is inserted into the devise and after adequate lubrication, the tool is inserted into the anal canal and rectum. The obturator is then removed. The anatomical site for banding is chosen, by acurate positioning the tool, A long narrow, angled tenaculum, or any other grasping device is inserted into the tube, the chosen tissue is grasped and pulled into the tube. The inner tube is retracted with the operators thumb and the outer barrel pushes the elastic band off the internal barrel and the band lodges around the tissue.
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