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510(k) Data Aggregation
K Number
K053322Device Name
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
Manufacturer
Date Cleared
2006-01-06
(37 days)
Product Code
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
ROEI MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Roei Working Element and Roei Cutting Loops are device accessories intended for use with monopolar resectoscope systems for the resection of soft tissue and are indicated for use in transuretheral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, and transurethral resection of the prostate (TURP).
Device Description
The Roei Working Element and Cutting Loops use the same fundamental operating characteristics as other resectoscope working elements and electrode cutting loops. The Roei Working Element includes an actuating handle, a tube to accommodate the optics, and a mechanism to which the disposable Roei Cutting Loops are attached. The proximal end of the Roei Working Element has a connection port for connection of a resectoscope optics element. The opposite end of the Roei Working Element has a connection port that accommodates a resectoscope sheath used to encase the tube and the Roei Cutting Loop. Additionally, the Roei Working Element provides an electrical connection box with an inlet receptacle for connection of a resectoscope's electrosurgical cable that is then attached to a monopolar electrosurgical generator. Once the Roei Working Element and Cutting Loop are attached to a resectoscope system, the Roei Cutting Loop receives electrical current from the electrosurgical generator. The electrical current transmitted to the Cutting Loop is then used to resect the targeted soft tissue.
In addition to serving as the housing for the Roei Cutting Loops, optics and electrical connections, the Roei Working Element permits translation of the axial motion of the handgrip into a circular axis movement of the Cutting Loop independent of the resectoscope sheath. This circular axis movement provides the ability for the surgeon to move the Cutting Loop in a side-to-side clockwise or counterclockwise direction through the soft tissue, according to the operating handle position. Furthermore, the Roei Working Element allows for a linear motion of the loop allowing complete retraction of the loop within the sheath during surgical procedures.
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K Number
K050910Device Name
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
Manufacturer
Date Cleared
2005-06-16
(66 days)
Product Code
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
ROEI MEDICAL TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Roei Working Element and Roei Cutting Loops are endoscopic electrosurgical accessories intended for use with monopolar resectoscope systems for the resection of soft tissue in transuretheral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, and transurethral resection of the prostate (TURP) procedures.
Device Description
The Roei Working Element and Cutting Loops use the same fundamental operating characteristics as other resectoscope working elements and electrode cutting loops. The Roei Working Element includes a handle and rod to which the disposable Roei Cutting Loops are attached. One end of the handle has a connection port for connection of a resectoscope optics element. The opposite end of the Roei Working Element handle has a connection port that accommodates a resectoscope sheath used to encase a Roei Cutting Loop. Additionally, the Roei Working Element handle provides an electrical connection box with an inlet receptacle for connection of a resectoscope's electrosurgical cable that is then attached to a monopolar electrosurgical generator. Once the Roei Working Element and Cutting Loop are attached to a resectoscope system, the Roei Cutting Loop receives electrical current from the electrosurgical generator. The electrical current transmitted to the Cutting Loop is then used to resect the targeted soft tissue.
In addition to serving as the housing for the Roei Cutting Loops, optics and electrical connections, the Roei Working Element permits translation of the axial motion of the handgrip into a circular axis movement of the Cutting Loop independent of the resectoscope sheath. This circular axis movement provides the ability for the surgeon to move the Cutting Loop in a side-to-side clockwise or counterclockwise direction through the soft tissue, according to the operating handle position.
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