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510(k) Data Aggregation
K Number
K102983Device Name
VASCUCLEAR PRECISION BIPOLAR
Manufacturer
Date Cleared
2010-11-01
(25 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
SORIN GROUP USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VascuClear Precision Bipolar is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of vessels.
Device Description
The VascuClear Precision Bipolar is a sterile, bipolar electrosurgical instrument with features to dissect, coagulate, and transect (cut) tissue with an integral knife blade. The device is compatible with a 5mm trocar and utilizes bipolar energy from standard bipolar generators. The instrument consists of three main parts as follows: 1. A handle with two sliding buttons. One button opens and closes the jaw of the device for grasping and clamping. The other button moves the integral knife blade back and forth. A standard pigtail cord is attached to the handle. 2. A shaft that connects the handle to the working end. The shaft is approximately 0.2 inches (5mm) in diameter and 16.5 inches (42cm) long from the handle to the tip of the instrument. 3. The working end of the instrument that consists of jaws, electrode surfaces and an integral knife with a dissecting tip.
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