FDA 510(k)

Single Lumen Ovum Aspiration Needles

K-Number: K171625 · 2018-01-12

ApplicantWillian A. Cook Australia Pty, Ltd.

Decision Date2018-01-12

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Single Lumen Ovum Aspiration Needles is the device name listed in this FDA 510(k) record. The listed applicant is Willian A. Cook Australia Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171625. 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 Single Lumen Ovum Aspiration Needles?

Single Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Willian A. Cook Australia Pty, Ltd.. The 510(k) number is K171625.

When did Single Lumen Ovum Aspiration Needles receive FDA 510(k) clearance?

Single Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171625.

Who is the listed applicant for Single Lumen Ovum Aspiration Needles?

The FDA 510(k) record lists Willian A. Cook Australia Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Lumen Ovum Aspiration Needles?

The FDA product code for Single Lumen Ovum Aspiration Needles is MQE.

Other records listing Willian A. Cook Australia Pty, Ltd. as applicant

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Related Devices (Code: MQE)

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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.