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510(k) Data Aggregation
K Number
K213786Device Name
CiRX Single use electrosurgical pencil with non-coated and coated electrode
Manufacturer
Date Cleared
2022-06-27
(203 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Ningbo Shun Ye Medical Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is to be used in combination with a standard electrosurgical generator to cut and coagniate soft tissus by means of high frequency electrical current during an electrosurgical procedure.
Device Description
The Single use electrosurgical pencil with electrode is a monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. It directs high frequency alternating current to heat target tissue thereby bringing about cutting and coagulation during surgical procedures.
The electrosurgical pencil handpiece consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.
The electrosurgical pencil handpiece is available in 3 models, differing only in their button configuration: Push Button Electrosurgical Pencil (Model #: GDSA), Electrosurgical Rocker Pencil (Model #: GDSB), and Electrosurgical Foot Control (Model #: GDJA).
The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball, needle and dermal tip. The electrode tip is either coated or noncoated. There may or may not be a heat shrink attached. There are 47 different types of electrodes.
The model number of each subjective device "Single use electrosurgical pencil with electrode" consists of two parts: the first four letters representing model number of the pencil, and the second part representing model number of the electrode. For example, model number: GDSA-DA-C66 is for Push Button Electrosurgical Pencil with Standard Blade 2.6". There are 141 different combinations of pencil and electrode.
The diameter of the conductive post is 2.36mm. The pencil with electrode attached is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.
The switching method of this electrosurgical pencil may be push button, rocker switch or foot switch. The cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug.
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K Number
K210256Device Name
CiRx (R) Surgical Mask
Manufacturer
Date Cleared
2021-08-19
(199 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Ningbo Shun Ye Medical Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for single use by operating room personnel healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluid, and particulate materials.
Device Description
The device is single use multi-layer surgical mask with outer layer and inner layer (spunbond plypropylene) that sandwich a meltblown polypropylene filter material. The surgical mask is secured on user via earloops. Earloops are made of polyester and spandex. The nose piece is a plastic covered iron strip. The materials used to make the surgical mask are being used in currently marketed surgical masks.
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