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Found 3 results
510(k) Data Aggregation
K Number
K160366Device Name
Electrosurgical disposable grounding pads
Manufacturer
TOP-RANK Health Care Co., Ltd
Date Cleared
2016-08-19
(192 days)
Product Code
ODR
Regulation Number
878.4400Why did this record match?
Product Code :
ODR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical disposable grounding pads are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
Device Description
Electrosurgical disposable grounding pads construct of a layer of conductive aluminum foil with a foam as the supportive base of the pad. The aluminum foil is coated with adhesive hydro-gel layer. There is another film placed above the adhesive hydro-gel layer, which is used to protect the gel during the transportation and storage and will be removed prior to use.
They are available in different combinations of configurations, types, intended populations and conductive area.
They are not provided in sterile conditions and not required to be sterilized by the end user prior to operation. However, they are for single use only.
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K Number
K121268Device Name
WANDY DISPERSVIE ELECTRODE
Manufacturer
BIO-MED USA INC.
Date Cleared
2012-12-20
(238 days)
Product Code
ODR
Regulation Number
878.4400Why did this record match?
Product Code :
ODR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator
Device Description
Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time.
The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric
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K Number
K082204Device Name
SERIES SY DISPOSABLE ELECTROSURGICAL PAD
Manufacturer
VENTLAB CORP.
Date Cleared
2008-08-13
(8 days)
Product Code
ODR
Regulation Number
878.4400Why did this record match?
Product Code :
ODR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Device Description
Not Found
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