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510(k) Data Aggregation
K Number
K180165Device Name
Habib EndoHPB
Manufacturer
EMcision Ltd.
Date Cleared
2018-03-20
(57 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
EMcision Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.
The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.
Device Description
The Habib EndoHPB is an 8F RF bipolar catheter that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel. It has an attached cable which connects the device to an RF Generator. RF is applied to the two electrodes at the top of the catheter so that heat is applied to tissue surrounding the catheter.
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K Number
K161305Device Name
Habib EUS RFA
Manufacturer
EMCISION LTD.
Date Cleared
2016-07-07
(58 days)
Product Code
GEI, JOS
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
EMCISION LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator.
Device Description
The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 Gauge (G) endoscopic needles. The subject device is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by means of coagulation necrosis.
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