TransferMan 4m Micromanipulator
by Eppendorf AG 510(k)
Active
510(k) K142207
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142207 | Date23 Jan 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
A micromanipulator designed to assist in the positioning of micro tools such as microcapillaries or micro glass pipettes under the microscope. It is used during assisted reproductive technologies (ART), including intracytoplasmic sperm injection (ICSI) and the collection of genetic material.
The device is supplied as a reusable instrument for use in clinical and laboratory settings. It is classified as a Class II medical device under FDA 510(k) clearance (K142207) with product code MQJ and regulation number 884.6150. No information on sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.