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FDA 510(k)

SperSort™ Sperm Sorting Chip (IPG02)

K-Number: K241626 · 2025-02-20

Decision Date2025-02-20
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SperSort™ Sperm Sorting Chip (IPG02) is a medical device manufactured by Ipreg Incorporation. It received FDA 510(k) clearance on 2025-02-20 under approval number K241626. 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 SperSort™ Sperm Sorting Chip (IPG02)?

SperSort™ Sperm Sorting Chip (IPG02) is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Ipreg Incorporation. The 510(k) number is K241626.

When was SperSort™ Sperm Sorting Chip (IPG02) approved by the FDA?

SperSort™ Sperm Sorting Chip (IPG02) received FDA 510(k) clearance on 2025-02-20, under approval number K241626.

What company makes SperSort™ Sperm Sorting Chip (IPG02)?

SperSort™ Sperm Sorting Chip (IPG02) is manufactured by Ipreg Incorporation.

What is the FDA product code for SperSort™ Sperm Sorting Chip (IPG02)?

The FDA product code for SperSort™ Sperm Sorting Chip (IPG02) is MQK.

Related Clinical Trials

Related Devices (Code: MQK)

Official Source

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