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FDA 510(k)

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

K-Number: K173955 · 2018-01-26

ApplicantHalyard Health, Inc.
Decision Date2018-01-26
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

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

When was Mic-Key* SF Over-the-Wire Stoma Measuring Device approved by the FDA?

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

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

Mic-Key* SF Over-the-Wire Stoma Measuring Device is manufactured by Halyard Health, Inc..

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.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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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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