MQEClass II
Needle, Assisted Reproduction
21 CFR 884.6100 / Obstetrics/Gynecology
MQE is the FDA product code for Needle, Assisted Reproduction, a class II device type, regulated under 21 CFR 884.6100. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- MQE
- Device name
- Needle, Assisted Reproduction
- Regulation
- 21 CFR 884.6100
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 33
- Ingested recalls
- 1
Clearances, product code MQE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1999 | 7 |
| 2000 | 5 |
| 2001 | 2 |
| 2003 | 4 |
| 2005 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 3 |
| 2024 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code MQE| Applicant | Clearances |
|---|---|
| <Genx> Intl., Inc. | 3 |
| CooperSurgical, Inc. | 3 |
| Abbott Medical | 3 |
| Vitrolife Sweden AB | 3 |
| Rocket Medical | 2 |
| William A. Cook Australia Pty, Ltd. | 2 |
| Allwin Medical Devices, Inc. | 1 |
| Casmed UK | 1 |
| Cook Ob/Gyn | 1 |
| Cook Incorporated | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Allwin Medical Devices Pvt. Ltd.
- Allwin Medical Devices, Inc.
- CIVCO Medical Instruments Co., Inc.
- Cook Incorporated
- Cook Medical LLC
- Cooper Medical, SRL
- CooperSurgical Distribution B.V.
- CooperSurgical, Inc.
- Dongguan King Medical Technology Co.,Ltd
- Eurofins STERIPAC GmbH
- Gimbo Medical Technology Shenzhen Co., Ltd.
- Gynetics Medical Products NV
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.