GENX MICROTOOLS
FDA 510(k) clearance K993884 · decided 2000-02-14
Clearance details
- K-number
- K993884
- Device name
- GENX MICROTOOLS
- Applicant
- <Genx> Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-16
- Decision date
- 2000-02-14
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MQJ
- Device class
- 2
- Regulation number
- 884.6150
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Madison, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TransferMan 4m Micromanipulator (K142207) | Eppendorf AG | 2015-01-23 |
| MICROMANIPULATOR SET (K120877) | Narishige Co., Ltd. | 2012-06-20 |
| IM-11 PNEUMATIC MICROINJECTOR (K113712) | Narishige Co., Ltd. | 2012-03-15 |
| MM-87 MOTOR-DRIVE MANIPULATOR (K011420) | Narishige Co., Ltd. | 2001-06-12 |
| MN-4 COARSE MANIPULATOR (K010298) | Narishige Co., Ltd. | 2001-03-16 |
| IM-5B MICROINJECTOR (K003303) | Narishige Co., Ltd. | 2000-11-22 |
| MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR (K003300) | Narishige Co., Ltd. | 2000-11-22 |
| IM-5A INJECTOR (K003302) | Narishige Co., Ltd. | 2000-11-22 |
| IM-6 MICROINJECTOR (K003304) | Narishige Co., Ltd. | 2000-11-22 |
| MICROMANIPULATOR (K003142) | Research Instruments , Ltd. | 2000-11-22 |
| MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR (K003298) | Narishige Co., Ltd. | 2000-11-21 |
| MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR (K002850) | Narishige Co., Ltd. | 2000-10-05 |
Recalls involving this device
No recalls on record reference this clearance.