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FDA 510(k)

MCCARTNEY ACCESS TUBE

K-Number: K051594 · 2005-09-02

ApplicantGynetech Pty. , Ltd.
Decision Date2005-09-02
Product CodeHEW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MCCARTNEY ACCESS TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Gynetech Pty. , Ltd.. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K051594. The device is classified under product code HEW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCCARTNEY ACCESS TUBE?

MCCARTNEY ACCESS TUBE is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Gynetech Pty. , Ltd.. The 510(k) number is K051594.

When did MCCARTNEY ACCESS TUBE receive FDA 510(k) clearance?

MCCARTNEY ACCESS TUBE received FDA 510(k) clearance on 2005-09-02, under 510(k) number K051594.

Who is the listed applicant for MCCARTNEY ACCESS TUBE?

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

What is the FDA product code for MCCARTNEY ACCESS TUBE?

The FDA product code for MCCARTNEY ACCESS TUBE is HEW.

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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.

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