MQHClass II
Microtools, Assisted Reproduction (Pipettes)
21 CFR 884.6130 / Obstetrics/Gynecology
MQH is the FDA product code for Microtools, Assisted Reproduction (Pipettes), a class II device type, regulated under 21 CFR 884.6130. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- MQH
- Device name
- Microtools, Assisted Reproduction (Pipettes)
- Regulation
- 21 CFR 884.6130
- 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
- 26
- Ingested recalls
- 4
Clearances, product code MQH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1999 | 7 |
| 2000 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 4 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2020 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code MQH| Applicant | Clearances |
|---|---|
| Cook Incorporated | 4 |
| Research Instruments Ltd | 3 |
| CooperSurgical, Inc. | 2 |
| Mid-Atlantic Diagnostics, Inc. | 2 |
| Sunlight Medical, Inc. | 2 |
| Swemed Lab International AB | 2 |
| Brinkmann Instruments, Inc. | 1 |
| Conception Technology, Inc. | 1 |
| Cook Ob/Gyn | 1 |
| Guangzhou PINZHI Medical Device Co., Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Arsci Inc.
- BBF Sterilisationsservice GmbH
- Cook Incorporated
- Cook Vandergrift, Inc.
- Cooper Medical, SRL
- CooperSurgical Distribution B.V.
- CooperSurgical, Inc.
- Greiner Mediscan GmbH, Sterilisationsanlage Seibe
- Guangzhou Huada Biotechnology Co., Ltd.
- Guangzhou PINZHI Medical Device Co., Ltd.
- Isomedix Operations Inc
- Research Instruments 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.