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FDA 510(k)

Follicle Aspiration Set

K-Number: K161970 · 2017-06-14

ApplicantVitrolife Sweden AB
Decision Date2017-06-14
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Follicle Aspiration Set is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K161970. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Follicle Aspiration Set?

Follicle Aspiration Set is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K161970.

When did Follicle Aspiration Set receive FDA 510(k) clearance?

Follicle Aspiration Set received FDA 510(k) clearance on 2017-06-14, under 510(k) number K161970.

Who is the listed applicant for Follicle Aspiration Set?

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

What is the FDA product code for Follicle Aspiration Set?

The FDA product code for Follicle Aspiration Set is MQE.

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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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