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510(k) Data Aggregation
K Number
K160041Device Name
Cobbra RF Tissue Dissector
Manufacturer
ELLIQUENCE LLC.
Date Cleared
2016-03-07
(59 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELLIQUENCE LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cobbra RF Tissue Dissector is intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.
Device Description
The Cobbra™ RF Tissue Dissector is a single-use, sterile, monopolar electrosurgical instrument intended for use exclusively with the elliquence Surgi-Max® Plus radiofrequency generator (510(k) K100390). The basic design of the device is a plastic handpiece, a partially-insulated electrode with an uninsulated, active edge, and a cable and plug. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active edge of the Cobbra™ RF Tissue Dissector's electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation.
The Cobbra™ RF Tissue Dissector is classified as a sterile, surgically-invasive, active device with an intended patient contact period of <1hr (transient). It is composed of 17-4PH medical-grade stainless steel, ABS plastic, PFA, PVC, and copper. The biocompatibility of patient contacting materials has been assured through appropriate testing in accordance with ISO 10993-1.
The Cobbra™ RF Tissue Dissector is individually-packaged and supplied EtO-sterilized for single use. It is available in five models which differ only by the diameter of the electrode: RF-COBB/XS (0.25 in.), RF-COBB/S (0.375 in.), RF-COBB/M (0.5 in.), RF-COBB/L (1.0 in.), and RF-COBB/XL (1.5 in.).
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