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510(k) Data Aggregation
K Number
K110462Device Name
KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
Manufacturer
KEPLER MEDTEC
Date Cleared
2011-09-26
(221 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
KEPLER MEDTEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kepler MedTec Disposable Bipolar Cables are intended to connect an electrosurgical device to an electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.
Device Description
The Kepler MedTec Disposable Bipolar Cable includes available in multiple colors. The Kepler MedTec Disposable Bipolar Cable is provided sterile.
Bipolar forceps (handpiece) are connected to a generator through a bipolar cable. The bipolar cable is flexible and delivers the electrical power from the generator to the binolar forcep. There is a male and female end termination on the cable. The male end termination (2-pin banana connector) is connected to the generator; the female end termination (2-pin plug type connector) to the bipolar forceps.
The Kepler MedTec Disposable Bipolar Cable is compatible with:
- Bipolar Forceps using standard US connection with 5.8 mm spaced pins .
- . VallyLab, Conmed, Medtronic and Bovie generators
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K Number
K101660Device Name
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
Manufacturer
KEPLER MEDTEC
Date Cleared
2010-08-11
(58 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
KEPLER MEDTEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kepler MedTec Single Patient Use ECG Lead Wire is a electrode cable system used to transmit signals from patient electrodes to various electrocardiograph recorders / monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. The Single Patient Use ECG Lead Wire Set is intended to be used by trained operators in a medical professional's environment.
Device Description
The Single Patient Use ECG Lead Wire is a single patient, electrode cable system used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. This type of device is common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
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