FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K Number: K003300
·
Decision Nov 22, 2000
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
22
Applicant Total
20
Review Days
33
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Basic Information
- Device Name
- MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
- K Number
- K003300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Narishige Co., Ltd.
- Date Received
- October 20, 2000
- Decision Date
- November 22, 2000
- Product Code
- MQJ
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Narishige Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K120877 | MICROMANIPULATOR SET | Jun 20, 2012 | Substantially Equivalent |
| K113712 | IM-11 PNEUMATIC MICROINJECTOR | Mar 15, 2012 | Substantially Equivalent |
| K011420 | MM-87 MOTOR-DRIVE MANIPULATOR | Jun 12, 2001 | Substantially Equivalent |
| K010298 | MN-4 COARSE MANIPULATOR | Mar 16, 2001 | Substantially Equivalent |
| K003304 | IM-6 MICROINJECTOR | Nov 22, 2000 | Substantially Equivalent |
| K003302 | IM-5A INJECTOR | Nov 22, 2000 | Substantially Equivalent |
| K003303 | IM-5B MICROINJECTOR | Nov 22, 2000 | Substantially Equivalent |
| K003298 | MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR | Nov 21, 2000 | Substantially Equivalent |
| K002850 | MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR | Oct 5, 2000 | Substantially Equivalent |
| K002659 | MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR | Sep 22, 2000 | Substantially Equivalent |