Denudation Pipettes
FDA 510(k) K250838 · Guangzhou Pinzhi Medical Device Co., Ltd.
510(k) numberK250838
Submission
- Device name
- Denudation Pipettes
- Applicant
- Guangzhou Pinzhi Medical Device Co., Ltd.
Guangzhou, CN - Received
- March 20, 2025
- Decision date
- July 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQH – Microtools, Assisted Reproduction (Pipettes)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6130
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Denudation Pipettes cleared by the FDA?
Denudation Pipettes (K250838) received a 510(k) decision of Substantially Equivalent on July 3, 2025, 105 days after the submission was received.
What is the product code of K250838?
The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.