FDA 510(k)

SperSort™ Sperm Sorting Chip (IPG02)

Número K: K241626 · 2025-02-20

Data da decisão2025-02-20

Código do produtoMQK

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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