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510(k) Data Aggregation
K Number
K151001Device Name
MUSE System
Manufacturer
MEDIGUS LTD.
Date Cleared
2015-06-05
(51 days)
Product Code
ODE
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDIGUS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medigus Ultrasonic Surgical Endostapler (MUSE™) System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
Device Description
The Medigus Ultrasonic Surgical Endostapler (MUSE™) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.
The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile (EtO) and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application.
The control console includes the insufflation, light and camera electronics.
The associated accessories include:
- Irrigation bottle with liquids for irrigation of the camera lens
- Silicon tubes for connecting the console and other accessories to the stapler
- Standard overtube for protecting patient's pharynx
- Tweezers to remove and replace staple cartridge
- Staple cartridges
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K Number
K143634Device Name
MUSE System
Manufacturer
MEDIGUS LTD.
Date Cleared
2015-01-20
(29 days)
Product Code
ODE
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDIGUS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MUSE System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy
Device Description
The MUSE system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile (EtO) and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application. The control console includes the insufflation, light and camera electronics. The associated accessories include: Irrigation bottle with liquids for irrigation of the camera lens, Silicon tubes for connecting the console and other accessories to the stapler, Standard overtube for protecting patient's pharynx, Tweezers to remove and replace staple cartridge, Staple cartridges.
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