Microtools, Assisted Reproduction (Pipettes)
FDA product code MQH · Class II (moderate risk) · 21 CFR 884.6130 · Obstetrics/Gynecology
26510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Research Instruments , Ltd. 3
- Humagen Fertility Diagnostics, Inc. 2
- Swemed Lab International AB 2
- Mid-Atlantic Diagnostics, Inc. 2
- Cook, Inc. 2
- Cook Urological, Inc. 2
- Sunlight Medical, Inc. 2
- Brinkmann Instruments, Inc. 1
- Guangzhou Pinzhi Medical Device Co., Ltd. 1
- Vitromed GmbH 1
- Life Global Group, LLC 1
- Jieying Laboratory, Inc. 1
- Irvine Scientific Sales Co., Inc. 1
- Cook Ob/Gyn 1
- Hunter Scientific Limited 1
- Pacific Andrology, Inc. 1
- Conception Technology, Inc. 1
- Prodimed 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250838 | Denudation PipettesMQH · Traditional | Guangzhou Pinzhi Medical Device Co., Ltd. | 07/03/2025SE |
| K192146 | V-DenupetMQH · Traditional | Vitromed GmbH | 01/28/2020SE |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripMQH · Traditional | Research Instruments Limited | 01/23/2017SE |
| K152581 | LifeGlobal Micro TipsMQH · Traditional | Life Global Group, LLC | 04/11/2016SE |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteMQH · Traditional | Cook Incorporated | 01/08/2016SE |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation PipetteMQH · Traditional | Cook Incorporated | 12/18/2015SE |
| K133257 | Biopsy PipettesMQH · Traditional | Research Instruments , Ltd. | 05/16/2014SE |
| K102480 | Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona…MQH · Traditional | Jieying Laboratory, Inc. | 04/19/2011SE |
| K092554 | Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesMQH · Traditional | Sunlight Medical, Inc. | 04/30/2010SE |
| K072600 | Intracytoplasmic Sperm and Spermatid Injection, Holding, Zone Drilling, Partial Zone…MQH · Traditional | Sunlight Medical, Inc. | 05/19/2008SE |
| K041435 | The Stripper PGDMQH · Traditional | Mid-Atlantic Diagnostics, Inc. | 09/29/2004SE |
| K041562 | CryotipMQH · Traditional | Irvine Scientific Sales Co., Inc. | 08/09/2004SE |
| K033904 | Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)MQH · Special | Cook Urological, Inc. | 01/16/2004SE |
| K033903 | Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes…MQH · Special | Cook Urological, Inc. | 01/16/2004SE |
| K024302 | Precision Capillaries for MicromanipulationMQH · Traditional | Brinkmann Instruments, Inc. | 02/19/2003SE |
| K022643 | Blastomere Biopsy Pipette, Models H-55530 and H-55540MQH · Traditional | Swemed Lab International AB | 11/05/2002SE |
| K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…MQH · Traditional | Humagen Fertility Diagnostics, Inc. | 02/11/2002SE |
| K001615 | Hunter Scientific Injection PipettesMQH · Traditional | Hunter Scientific Limited | 08/18/2000SE |
| K993699 | The StripperMQH · Traditional | Mid-Atlantic Diagnostics, Inc. | 05/16/2000SE |
| K991388 | Assisted Hatching Micropipettes, Denuding Pipettes, Holding Micropipettes, Icsi…MQH · Traditional | Pacific Andrology, Inc. | 09/13/1999SE |
| K991261 | Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette, Assisted…MQH · Traditional | Research Instruments , Ltd. | 08/05/1999SE |
| K991700 | Swemed Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes; Holding…MQH · Traditional | Swemed Lab International AB | 07/19/1999SE |
| K991104 | MicrotoolsMQH · Traditional | Conception Technology, Inc. | 07/19/1999SE |
| K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding…MQH · Traditional | Humagen Fertility Diagnostics, Inc. | 07/14/1999SE |
| K983713 | Prodimed Microinjection PipettesMQH · Traditional | Prodimed | 06/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | Cook Ob/Gyn | 02/05/1999SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1367-2019 Class II | ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent | CooperSurgical, Inc. | 03/27/2019Terminated |
| Z-2177-2008 | Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic…mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | Cook Vascular Inc. | 03/02/2008Terminated |
| Z-2176-2008 | Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The…mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | Cook Vascular Inc. | 03/02/2008Terminated |
| Z-2178-2008 | Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10…mislabeled - 300 micron flexipets were labeled as 80 microns | Cook Vascular Inc. | 12/17/2007Terminated |