IM-9C Microinjectors
510(k) K001910
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001910 | Date7 Jul 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.6150
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The IM-9C Microinjectors are pneumatic microinjectors designed for maintenance-free operation. These devices feature a mechanism that reduces fluctuations of handle tension, allowing for smooth control when handling large volumes of liquid. They are operated pneumatically to avoid maintenance issues such as topping up oil, refilling, or removing air bubbles.
The IM-9C Microinjectors are supplied by Narishige Co., Ltd. and are intended for use in obstetrics and gynecology applications. The device has received FDA 510(k) clearance with a product code of MQJ and is classified as a Class II medical device. It is recommended for use in microinjection and drug application systems, though specific sterility and single-use or reusable status are not specified in the provided data.
Other devices from Narishige Co., Ltd.
Questions
AI-generated answers, 26 Sep 2026
What are the IM-9C Microinjectors designed for?
The IM-9C Microinjectors are pneumatic microinjectors designed for maintenance-free operation, featuring a mechanism that reduces handle tension fluctuations for smooth control when handling large volumes of liquid in obstetrics and gynecology applications.
How are the IM-9C Microinjectors operated and maintained?
These devices are operated pneumatically to avoid maintenance issues such as topping up oil, refilling, or removing air bubbles, making them suitable for continuous use without regular maintenance requirements.
What is the regulatory status of the IM-9C Microinjectors?
The IM-9C Microinjectors have received FDA 510(k) clearance with product code MQJ and are classified as a Class II medical device, specifically for use in microinjection and drug application systems in obstetrics and gynecology.
Are the IM-9C Microinjectors single-use or reusable?
The provided data does not specify whether the IM-9C Microinjectors are single-use or reusable devices, nor does it indicate their sterility status, so this information would need to be obtained directly from the manufacturer.