G-Vitri Vitrification Straw
FDA 510(k) K240002 · Gimbo Medical Technology Shenzhen Co., Ltd.
510(k) numberK240002
Submission
- Device name
- G-Vitri Vitrification Straw
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd.
Shenzhen, CN - Received
- January 2, 2024
- Decision date
- June 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MQK – Labware, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241626 | SperSort Sperm Sorting Chip (IPG02)MQK · Traditional | Ipreg Incorporation | 02/20/2025SE |
| K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB…MQK · Traditional | Guangzhou Hehong Biotech Co., Ltd. | 02/03/2025SE |
| K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)MQK · Traditional | Motilitycount Aps | 01/31/2025SE |
| K241341 | cryo-GO Vitrification DeviceMQK · Traditional | Fujifilm Irvine Scientific | 09/26/2024SE |
| K232980 | SpermAlign Sperm Separation DeviceMQK · Traditional | Cytoswim, Ltd. | 03/14/2024SE |
| K233177 | Nest VT Vitrification DeviceMQK · Traditional | Cook Incorporated | 03/08/2024SE |
| K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceMQK · Traditional | Bonraybio Co., Ltd. | 10/31/2022SE |
| K213869 | EmbryoSlide+ ic8 dishMQK · Traditional | Vitrolife A/S | 03/11/2022SE |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification StrawMQK · Traditional | Allwin Medical Devices, Inc. | 06/04/2021SE |
| K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mLMQK · Traditional | Hertart Aps | 12/16/2020SE |
More from Hertart Aps
| 510(k) | Device | Decision |
|---|---|---|
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval…MQE · Traditional | 06/15/2026SE |
| K242043 | Sperm Freezing MediumMQL · Traditional | 01/08/2025SE |
| K242968 | Giftlife® Single-Step Medium PlusMQL · Traditional | 11/22/2024SE |
| K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium…MQL · Traditional | 06/13/2024SE |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete BufferMQL · Traditional | 05/10/2024SE |
| K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing MediaMQL · Traditional | 01/30/2024SE |
Questions and answers
When was G-Vitri Vitrification Straw cleared by the FDA?
G-Vitri Vitrification Straw (K240002) received a 510(k) decision of Substantially Equivalent on June 14, 2024, 164 days after the submission was received.
What is the product code of K240002?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.