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510(k) Data Aggregation
K Number
K163214Device Name
Unicare System, Unicare Manipulator
Manufacturer
Date Cleared
2017-02-07
(83 days)
Product Code
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
ClearPath Surgical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Unicare System is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum during a colpotomy.
The Unicare Manipulator is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, such as minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy.
Device Description
The new Unicare System™ is a sterile, disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The Unicare System™ consists of the Unicare Manipulator™, a rear Stabilizer™, and a set of interchangeable, forward Collars™.
The Unicare Manipulator™ is a rigid, anatomically curved cannula having at its proximal end a tip for insertion into the uterus to manipulate and maintain the proper attitude of the uterus. The Unicare Manipulator incorporates a sliding tube component with a proximal ball that provides a positive stop from over-penetration of the uterine cavity and counter traction with the tip for manipulation. At the distal end of the device is a handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme distal end of the device is a standard luer port suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the cannula.
The Unicare System also incorporates a set of interchangeable, forward Collars™ and a rear Stabilizer™. The appropriately sized Collar surrounds the cervix, delineates the fornix, and supports and defines the vaginal wall. The rear Stabilizer and a sliding tube are slid along the cannula to adjust the depth of tip insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear Stabilizer and sliding tube components are secured at their proper depth with a locking mechanism situated distal to the sliding tube and external to the patient.
The Unicare Manipulator™ will be offered and sold separately from the Unicare System™. The Unicare Manipulator"™ does not include a rear Stabilizer" or a set of interchangeable, forward Collars", and is therefore indicated only for a subset of procedures of the Unicare System™
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