Cleared Special

K173955 - Mic-Key* SF Over-the-Wire Stoma Measuri...

K173955 is an FDA 510(k) clearance for Mic-Key* SF Over-the-Wire Stoma Measuri..., manufactured by Halyard Health, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 29-day FDA review.

K173955 · Halyard Health, Inc. · Gastroenterology & Urology device
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Jan 2018
Decision
29d
Days
Class 2
Risk

K173955 is an FDA 510(k) clearance for the Mic-Key* SF Over-the-Wire Stoma Measuring Device. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Halyard Health, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 26, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Halyard Health, Inc. devices

FDA 510(k) Submission Details - K173955

510(k) Number K173955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 28, 2017
Decision Date January 26, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 341
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