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FDA 510(k)

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

K-Number: K212410 · 2022-02-01

ApplicantShenzhen Vitavitro Biotech Co., Ltd.
Decision Date2022-02-01
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is a medical device manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-01 under approval number K212410. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is a medical device that received FDA 510(k) clearance on 2022-02-01. It is manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. The 510(k) number is K212410.

When was VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium approved by the FDA?

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium received FDA 510(k) clearance on 2022-02-01, under approval number K212410.

What company makes VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is manufactured by Shenzhen Vitavitro Biotech Co., Ltd..

What is the FDA product code for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium?

The FDA product code for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium is MQL.

Related Clinical Trials

NCT07605182 Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age NOT_YET_RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Shenzhen Vitavitro Biotech Co., Ltd.

K1910631-Step Culture Medium K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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