MQFClass II
Catheter, Assisted Reproduction
21 CFR 884.6110 / Obstetrics/Gynecology
MQF is the FDA product code for Catheter, Assisted Reproduction, a class II device type, regulated under 21 CFR 884.6110. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 36 recalls.
Classification record
- Product code
- MQF
- Device name
- Catheter, Assisted Reproduction
- Regulation
- 21 CFR 884.6110
- 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
- 53
- Ingested recalls
- 36
Clearances, product code MQF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1998 | 4 |
| 1999 | 7 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 5 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2010 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2015 | 2 |
| 2017 | 6 |
| 2018 | 5 |
| 2019 | 2 |
| 2020 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code MQF| Applicant | Clearances |
|---|---|
| CooperSurgical, Inc. | 8 |
| Cook Incorporated | 7 |
| Cook Ob/Gyn | 5 |
| Fertility Technology Resources, Inc. | 3 |
| Kitazato Corporation | 3 |
| Allwin Medical Devices, Inc. | 2 |
| Fertiligent, Ltd. | 2 |
| Gynetics Medical Products NV | 2 |
| Inntec, Inc. | 2 |
| Kitazato Medical Co., Ltd. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Allwin Medical Devices Pvt. Ltd.
- Allwin Medical Devices, Inc.
- Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti
- CGN Gray (Shenzhen) Technology Co., Ltd.
- Cook Incorporated
- Cook Medical LLC
- Cooper Medical, SRL
- CooperSurgical Distribution B.V.
- CooperSurgical, Inc.
- Dongguan King Medical Technology Co.,Ltd
- Femasys Inc.
- Guangzhou Hehong Biotech Co., Ltd.
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.
