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510(k) Data Aggregation
K Number
K152702Device Name
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
Manufacturer
Date Cleared
2016-02-18
(150 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ENT BIOTECH SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ENT Biotech Solutions Tissue Removal Device (Elasso™) is intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).
Device Description
The ENT Biotech Solutions tissue removal device (also referred to as the "Elasso™") is a single-use, surgical accessory, used with a recommended electrosurgical generator (not supplied by ENT Biotech Solutions, INC) and associated equipment (monopolar cord and patient return electrode). The Elasso device configuration is similar to a standard forceps geometry (patterned after the commercially available reference device, St. Clair Forceps), but with an integrated loop electrode at the distal tip of one of the forceps. The proximal end contains a single banana pluq. for connection to the generator. The hand piece is operated by the generator's footswitch controller. The Elasso™ is a single-use, sterile packaged device.
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