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FDA 510(k)

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette

K-Number: K151018 · 2016-01-08

ApplicantCook Incorporated
Decision Date2016-01-08
Product CodeMQH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-01-08 under approval number K151018. The device is classified under product code MQH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette?

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette is a medical device that received FDA 510(k) clearance on 2016-01-08. It is manufactured by Cook Incorporated. The 510(k) number is K151018.

When was Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette approved by the FDA?

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette received FDA 510(k) clearance on 2016-01-08, under approval number K151018.

What company makes Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette?

Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette is manufactured by Cook Incorporated.

What is the FDA product code for Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette?

The FDA product code for Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette is MQH.

Related Clinical Trials

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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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