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FDA 510(k)

SperSort™ Sperm Sorting Chip (IPG02)

K-Number: K241626 · 2025-02-20

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

Device Summary

SperSort™ Sperm Sorting Chip (IPG02) is the device name listed in this FDA 510(k) record. The listed applicant is Ipreg Incorporation. It received FDA 510(k) clearance on 2025-02-20 under 510(k) 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. The listed applicant is Ipreg Incorporation. The 510(k) number is K241626.

When did SperSort™ Sperm Sorting Chip (IPG02) receive FDA 510(k) clearance?

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

Who is the listed applicant for SperSort™ Sperm Sorting Chip (IPG02)?

The FDA 510(k) record lists Ipreg Incorporation as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: MQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount ApsK241341cryo-GO Vitrification DeviceFujifilm Irvine ScientificK240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.K233177Nest VT Vitrification DeviceCook Incorporated

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.

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