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510(k) Data Aggregation
K Number
K243821Device Name
i-Cut
Manufacturer
A.M.I. Agency for Medical Innovations GmbH
Date Cleared
2025-04-25
(134 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
A.M.I. Agency for Medical Innovations GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.
Device Description
The i-Cut is a single use laparoscopic power morcellator. It is provided sterile.
The i-Cut consists of a rotating cutting tube with a trocar that provides protection against the cutting blade when locked in the "CLOSED" position. The device comes with an obturator for placement into the patient's body and a locking clip that keeps the trocar in the "closed" position during insertion. The activation button must be pressed to cut tissue.
The lumen of the device is designed for use with a standard grasper or Tenaculum forceps with a diameter between 10 to 14 mm. The i-Cut is designed to be used with surgical instruments of diameters between 10 to 14 mm. The lumen is fitted with a silicone valve to prevent gas loss during use of the device.
The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
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