Micromanipulator
510(k) K003142
Micromanipulator is a Class II device made by Research Instruments, Ltd., cleared under FDA 510(k) K003142 on 22 Nov 2000, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003142 | Date22 Nov 2000 | StatusActive |
Official records
- FDA 510(k) database K003142
Recalls
-
- Terminated Z-1584-2016
The units have been fitted with a potentially faulty power supply cable.
Timeline
- Cleared FDA 510(k) K003142
- Recall initiated FDA recalls Z-1584-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQJ
- FDA applicant
- Research Instruments , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6150
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K003142
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| INTEGRA 3 | 6-54-100-03 / Integra 3 Thermosafe Nikon 1 x SAS & 1 x SAS-SE | 05060488041778 | — | On the market |
| INTEGRA 3 | 6-54-100-07 / Integra 3 Thermosafe Olympus 1 x SAS & 1 x SAS-SE | 05060488041815 | — | On the market |
| INTEGRA 3 | 6-54-100-09 / Integra 3 Thermosafe Leica DMi No Syringes | 05060488042416 | — | On the market |
| INTEGRA 3 | 6-54-100-11 / Integra 3 Thermosafe Leica DMi 1 x SAS, 1 x SAS-SE | 05060488042447 | — | On the market |
| INTEGRA 3 | 6-54-100-12 / Integra 3 Thermosafe Leica DMi 2 x SAS-SE | 05060488042430 | — | On the market |
| INTEGRA 3 | 6-54-100-14 / Integra 3 Thermosafe Nikon Ti2 No Syringes | 05060488044755 | — | On the market |
| INTEGRA 3 | 6-54-100-16 / Integra 3 Thermosafe Nikon Ti2 1 x SAS 1 x SAS-SE | 05060488044779 | — | On the market |
| INTEGRA 3 | 6-54-100-17 / Integra 3 Thermosafe Nikon Ti2 2 x SAS-SE | 05060488044786 | — | On the market |
| INTEGRA 3 | 6-54-100-18 / Integra 3 Thermosafe Olympus IX1 No Syringes | 05060488044984 | — | On the market |
| INTEGRA 3 | 6-54-100 / INTEGRA 3 micromanipulation System with Thermosafe | 05060170185056 | — | On the market |
| INTEGRA 3 | 6-54-110-02 / Integra 3 no Thermosafe with ITO Leica DMi 2xSAS | 05060488042782 | — | On the market |
| INTEGRA 3 Micromanipulation System | 6-54-110 / INTEGRA 3 Micromanipulation System | 05060170185063 | — | On the market |
| Integra 3 No Thermosafe Leica DMI 2xSAS | 6-54-110-01 / Integra 3 No Thermosafe Leica DMI 2xSAS | 05060488043451 | — | On the market |
| Integra 3 Thermosafe Leica DMi 2 x SAS | 6-54-100-10 / Integra 3 Thermosafe Leica DMi 2 x SAS | 05060488042423 | — | On the market |
| Integra 3 Thermosafe Nikon 2 x SAS | 6-54-100-02 / Integra 3 Thermosafe Nikon 2 x SAS | 05060488041761 | — | On the market |
| Integra 3 Thermosafe Nikon 2 x SAS-SE | 6-54-100-04 / Integra 3 Thermosafe Nikon 2 x SAS-SE | 05060488041785 | — | On the market |
| Integra 3 Thermosafe Nikon No Syringes | 6-54-100-01 / Integra 3 Thermosafe Nikon No Syringes | 05060488041754 | — | On the market |
| Integra 3 Thermosafe Nikon Ti2 2 x SAS | 6-54-100-15 / Integra 3 Thermosafe Nikon Ti2 2 x SAS | 05060488044762 | — | On the market |
| Integra 3 Thermosafe Olympus 2 x SAS | 6-54-100-06 / Integra 3 Thermosafe Olympus 2 x SAS | 05060488041808 | — | On the market |
| Integra 3 Thermosafe Olympus 2 x SAS-SE | 6-54-100-08 / Integra 3 Thermosafe Olympus 2 x SAS-SE | 05060488041822 | — | On the market |
| Integra 3 Thermosafe Olympus IX1 2xSAS | 6-54-100-13 / Integra 3 Thermosafe Olympus IX1 2xSAS | 05060488043611 | — | On the market |
| Integra 3 Thermosafe Olympus No Syringes | 6-54-100-05 / Integra 3 Thermosafe Olympus No Syringes | 05060488041792 | — | On the market |
| RI Syringe Air Syringe - SAS | 6-34-520 / Air Syringe - SAS | 05060170180037 | — | On the market |
| RI Syringe Air Syringe - SAS SE | 6-34-530 / Air Syringe - SAS SE | 05060170180044 | — | On the market |
| RI Syringe Oil Syringe - SOS | 6-34-700 / Oil Syringe - SOS | 05060170180051 | — | On the market |
Similar devices
Other devices filed under FDA product code MQJ (Micromanipulators And Microinjectors, Assisted Reproduction).
- 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE by Narishige Co., Ltd.
- MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR by Narishige Co., Ltd.
- TransferMan 4m Micromanipulator by Eppendorf AG
- GENX MICROTOOLS by <Genx> Intl., Inc.
- RI Syringe Air Syringe - SAS 6-34-520 by Research Instruments, Ltd.
- RI Syringe Oil Syringe - SOS 6-34-700 by Research Instruments, Ltd.