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510(k) Data Aggregation
K Number
K160149Device Name
Miret Grasper, Alligator, Miret Grasper, Maryland
Manufacturer
Date Cleared
2016-08-30
(222 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MIRET SURGICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Miret Surgical Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate soft tissues.
Device Description
Fabricated from a stainless steel alloy, Miret Surgical Instruments are single-use disposable devices designed for grasping, holding and manipulating tissue. They consist of an integrated needle/cannula shaft that attaches to a working instrument. The shaft can be introduced percutaneously to the surgical site, after which the working instrument can be operated. The working instrument is controlled through a handle and locking mechanism on the proximal end of the device. The Miret Surgical Instruments can be used in a variety of surgical applications, including laparoscopic surgery after insufflation, and are available in either a Maryland or Alligator grasper configuration.
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