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510(k) Data Aggregation
K Number
DEN230032Device Name
Symani Surgical System
Manufacturer
Date Cleared
2024-04-05
(346 days)
Regulation Number
878.4963Why did this record match?
Applicant Name (Manufacturer) :
MMI North America, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis. suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities.
The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.
Device Description
The Symani Surgical System is designed for open microsurgery procedures, featuring articulated and interchangeable instruments.
The surgeon manipulates the Master Controllers, which in turn drive the articulated (wristed) robotic Instruments at the operating table/site, replicating and scaling down the surgeon movements using a chosen scaling factor. Symani is used in combination with conventional surgical microscopes, either optical or digital.
Symani is composed of three main components (Figure 1):
- The Console, which is a reusable equipment and not sterile; .
- The Cart with Macropositioner and two Micromanipulators, which is a reusable equipment . and not sterile: and
- . Two articulated Instruments, which are single-use and terminally sterilized via ethylene oxide
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