MQJ · Micromanipulators And Microinjectors, Assisted Reproduction
Obstetrics/Gynecology · 21 CFR 884.6150 · Class 2
Overview
| Product Code | MQJ |
|---|---|
| Device Name | Micromanipulators And Microinjectors, Assisted Reproduction |
| Regulation | 21 CFR 884.6150 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.
Classification Rationale
Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Special Controls
*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142207 | TransferMan 4m Micromanipulator | Eppendorf AG | Jan 23, 2015 | SESE |
| K120877 | MICROMANIPULATOR SET | Narishige Co., Ltd. | Jun 20, 2012 | SESE |
| K113712 | IM-11 PNEUMATIC MICROINJECTOR | Narishige Co., Ltd. | Mar 15, 2012 | SESE |
| K011420 | MM-87 MOTOR-DRIVE MANIPULATOR | Narishige Co., Ltd. | Jun 12, 2001 | SESE |
| K010298 | MN-4 COARSE MANIPULATOR | Narishige Co., Ltd. | Mar 16, 2001 | SESE |
| K003304 | IM-6 MICROINJECTOR | Narishige Co., Ltd. | Nov 22, 2000 | SESE |
| K003303 | IM-5B MICROINJECTOR | Narishige Co., Ltd. | Nov 22, 2000 | SESE |
| K003302 | IM-5A INJECTOR | Narishige Co., Ltd. | Nov 22, 2000 | SESE |
| K003300 | MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR | Narishige Co., Ltd. | Nov 22, 2000 | SESE |
| K003142 | MICROMANIPULATOR | Research Instruments , Ltd. | Nov 22, 2000 | SESE |
| K003298 | MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR | Narishige Co., Ltd. | Nov 21, 2000 | SESE |
| K002850 | MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR | Narishige Co., Ltd. | Oct 5, 2000 | SESE |
| K002659 | MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR | Narishige Co., Ltd. | Sep 22, 2000 | SESE |
| K002658 | MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR | Narishige Co., Ltd. | Sep 22, 2000 | SESE |
| K002653 | MMN-1 COARSE MANIPULATOR | Narishige Co., Ltd. | Sep 22, 2000 | SESE |
| K002293 | 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE | Narishige Co., Ltd. | Sep 13, 2000 | SESE |
| K002291 | MOTOR-DRIVE MANIPULATOR MM-89 | Narishige Co., Ltd. | Sep 13, 2000 | SESE |
| K001912 | IM-9B MICROINJECTORS | Narishige Co., Ltd. | Jul 7, 2000 | SESE |
| K001911 | IM-9A MICROINJECTORS | Narishige Co., Ltd. | Jul 7, 2000 | SESE |
| K001910 | IM-9C MICROINJECTORS | Narishige Co., Ltd. | Jul 7, 2000 | SESE |
Top Applicants
- Narishige Co., Ltd. — 20 clearances
- <Genx> Intl., Inc. — 1 clearance
- Eppendorf AG — 1 clearance
- Research Instruments , Ltd. — 1 clearance
