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Found 20 results
510(k) Data Aggregation
K Number
K120877Device Name
MICROMANIPULATOR SET
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2012-06-20
(89 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures.
Device Description
The NAI-5 Micromanipulator Set enables coarse and fine positioning of a microtool under the microscope and is used in assisted reproduction procedures. The NAI-5 Micromanipulator Set consists of motor driven coarse manipulators that enable coarse movement operation and oil hydraulic micromanipulators that enable fine movement operation.
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K Number
K113712Device Name
IM-11 PNEUMATIC MICROINJECTOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2012-03-15
(87 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.
Device Description
The IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into occytes, and to hold oocytes during the ICSI procedure.
The IM-11 Pneumatic Microinjector is a manually operated pneumatically actuated screw driven microinjector incorporating coarse and fine control knobs. The coarse control knob is used to perform coarse movement operation while the fine control knob is used to perform fine movement operation. It is easy to use simply by turning the control knob clockwise for injection and counterclockwise for aspiration.
The IM-11 Pneumatic Microinjector is a component part of a micromanipulator system.
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K Number
K011420Device Name
MM-87 MOTOR-DRIVE MANIPULATOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2001-06-12
(34 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010298Device Name
MN-4 COARSE MANIPULATOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2001-03-16
(44 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003300Device Name
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2000-11-22
(33 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003302Device Name
IM-5A INJECTOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2000-11-22
(33 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003303Device Name
IM-5B MICROINJECTOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2000-11-22
(33 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003304Device Name
IM-6 MICROINJECTOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2000-11-22
(33 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003298Device Name
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2000-11-21
(32 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002850Device Name
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
Manufacturer
NARISHIGE CO., LTD.
Date Cleared
2000-10-05
(22 days)
Product Code
MQJ
Regulation Number
884.6150Why did this record match?
Applicant Name (Manufacturer) :
NARISHIGE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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