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510(k) Data Aggregation
K Number
K110819Device Name
SINGHMED ROOLIP MANIPULATOR
Manufacturer
J.SINGH INSTRUMENTS
Date Cleared
2011-10-05
(196 days)
Product Code
HEW, LKF
Regulation Number
884.1640Why did this record match?
Applicant Name (Manufacturer) :
J.SINGH INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Singh Colpotomizer System is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required. The surgeon makes the colpotomy incisions to access or remove intraperitoneal tissue.
Device Description
The Singh Colpotomizer System is comprised of a reusable uterine manipulator with cervical screw attachment, a reusable sliding uterine tip (inner rod), reusable sliding and rotating funnels with a lip acting as a colpotomizer, an O ring and screw to hold the funnel in place, and a vaginal plug. The funnels are available in two sizes: 35 and 40mm.
In Laparoscopic Hysterectomy, the Uterine Cannula is inserted into the Uterus. The Vaginal Funnel slides onto the Uterine Cannula and is rotated manually during the operation to lift the Vaginal Wall for identification and incision during Laparoscopic Hysterectomy. This identifies the uterine arteries and ureters during this procedure.
Stainless steel and medical grade plastics are used in the manufacture of the subject device.
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