Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
FDA 510(k) K241454 · Guangzhou Hehong Biotech Co., Ltd.
510(k) numberK241454
Submission
- Device name
- Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
- Applicant
- Guangzhou Hehong Biotech Co., Ltd.
Guangzhou, CN - Received
- May 22, 2024
- Decision date
- February 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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
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| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…MQF · Traditional | 02/12/2026SE |
Questions and answers
When was Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) cleared by the FDA?
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) (K241454) received a 510(k) decision of Substantially Equivalent on February 3, 2025, 257 days after the submission was received.
What is the product code of K241454?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.