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510(k) Data Aggregation
K Number
K170703Device Name
Single Use Arthroscopic Electrode (with Pencil)
Manufacturer
Modern Medical Equipment Manufacturing Limited
Date Cleared
2018-05-31
(449 days)
Product Code
HRX, GEI
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Modern Medical Equipment Manufacturing Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.
Device Description
Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration offers 90° Angled Hook, 45° Angled Hook and Blade to meet the needs of Arthroscopy. The conductive electrode tip is the conductive portion of the electrode which delivers RF energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures. The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material (Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode. The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.
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K Number
K163442Device Name
Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
Manufacturer
Modern Medical Equipment Manufacturing Limited
Date Cleared
2017-09-28
(294 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Modern Medical Equipment Manufacturing Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure
Device Description
The Single Use Micro Electrodes are the monopolar active device which consist of a conductive electrode tip, an insulated shaft and a conductive post.
The conductive electrode tip configuration includes micro needles, scalpel blade, ball, broadbent, wire, triangle loop, diamond loop and round loop.
The conductive electrode tip is the conductive portion of the electrode which delivers high frequency current onto a soft tissue for cutting and coagulation during an electro-surgery
The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material included Polyolefin and /or PTFE Shrink Wrap, overmold, in order to prevent accidental conduction of the electrosurgical current from this point to the patient.
The conductive post is used to pluq the electrode into the nozzle of an electrosurgical pencil from which it receives the electrical current. The diameter of the conductive post is available in 2.36mm and 1.6mm.
This device is used in conjunction with electrosurgical pencil, a compatible monopolar electrosurgical generator and patient grounding pad during electrosurgical procedure.
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K Number
K152059Device Name
Disposable General Electrode
Manufacturer
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
Date Cleared
2016-04-21
(272 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The electrode is used to cut and / or coagulate soft tissues by means of high frequency electrical current during an electrosurgical procedure.
Device Description
Disposable General Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is categorized by three families: Blade, Needle and Ball. Each electrode family offers three series S, M and L in length and different insulation designs. The conductive post of electrode is inserted into the nozzle of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in electrosurgical procedure. This device is used in conjunction with a compatible monopolar electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
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K Number
K134006Device Name
DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE
Manufacturer
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
Date Cleared
2014-11-21
(329 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The electrode is used to cut and coagulate the selected tissue for laparoscopic procedures.
Device Description
Disposable Laparoscopic Electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip is either coated or non-coated and the conductive post is either 2.36mm or 4mm. The conductive post is inserted into the electrode entry of electrosurgical pencil from which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in laparoscopic procedure. During the operation, the electrode tip and the insulated shaft are to be inserted through a 5mm trocar. This device is used in conjunction with a compatible electrosurgical generator and patient grounding pad and complies with IEC60601-1 and IEC60601-2-2.
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