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FDA 510(k)

Mic-Key* SF Over-the-Wire Stoma Measuring Device

K-Number: K173955 · 2018-01-26

Decision Date2018-01-26
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

Mic-Key* SF Over-the-Wire Stoma Measuring Device is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health, Inc.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K173955. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Mic-Key* SF Over-the-Wire Stoma Measuring Device?

Mic-Key* SF Over-the-Wire Stoma Measuring Device is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Halyard Health, Inc.. The 510(k) number is K173955.

When did Mic-Key* SF Over-the-Wire Stoma Measuring Device receive FDA 510(k) clearance?

Mic-Key* SF Over-the-Wire Stoma Measuring Device received FDA 510(k) clearance on 2018-01-26, under 510(k) number K173955.

Who is the listed applicant for Mic-Key* SF Over-the-Wire Stoma Measuring Device?

The FDA 510(k) record lists Halyard Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mic-Key* SF Over-the-Wire Stoma Measuring Device?

The FDA product code for Mic-Key* SF Over-the-Wire Stoma Measuring Device is KNT.

Other records listing Halyard Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.