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FDA 510(k)

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

K-Number: K221810 · 2022-10-31

ApplicantBonraybio Co., Ltd.
Decision Date2022-10-31
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device is a medical device manufactured by Bonraybio Co., Ltd.. It received FDA 510(k) clearance on 2022-10-31 under approval number K221810. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device?

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device is a medical device that received FDA 510(k) clearance on 2022-10-31. It is manufactured by Bonraybio Co., Ltd.. The 510(k) number is K221810.

When was LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device approved by the FDA?

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device received FDA 510(k) clearance on 2022-10-31, under approval number K221810.

What company makes LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device?

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device is manufactured by Bonraybio Co., Ltd..

What is the FDA product code for LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device?

The FDA product code for LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device is MQK.

Related Clinical Trials

NCT07605182 Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age NOT_YET_RECRUITING NCT06238570 Validation of Donor Oocytes Semi-automated Vitrification RECRUITING NCT04907071 Intravascular Ultrasound for the Evaluation of Malperfusion Syndrome in the Setting of Acute Aortic Dissection COMPLETED

Other Devices by Bonraybio Co., Ltd.

K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer K242388LensHooke X12 PRO Semen Analysis System

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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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