V-Denupet
FDA 510(k) K192146 · Vitromed GmbH
510(k) numberK192146
Submission
- Device name
- V-Denupet
- Applicant
- Vitromed GmbH
Jena, DE - Received
- August 8, 2019
- Decision date
- January 28, 2020
- 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
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|---|---|---|---|
| K250838 | Denudation PipettesMQH · Traditional | Guangzhou Pinzhi Medical Device Co., Ltd. | 07/03/2025SE |
| 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 |
More from Mid-Atlantic Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K232125 | V-PvpMQL · Traditional | 03/20/2024SE |
| K222606 | V-HyadaseMQL · Traditional | 05/26/2023SE |
| K223117 | V-Sperm WashMQL · Traditional | 01/31/2023SE |
| K193285 | V-OnestepMQL · Traditional | 11/20/2020SE |
Questions and answers
When was V-Denupet cleared by the FDA?
V-Denupet (K192146) received a 510(k) decision of Substantially Equivalent on January 28, 2020, 173 days after the submission was received.
What is the product code of K192146?
The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.