Mic-Key* SF Over-the-Wire Stoma Measuring Device— 510(k) K173955

Name: FDA 510(k) clearance K173955
Creator: U.S. Food and Drug Administration
Published: 2018-01-26

Unknown

Halyard Health, Inc.

FDA 510(k) clearance K173955 for Mic-Key* SF Over-the-Wire Stoma Measuring Device, Unknown on 2018-01-26. Applicant: Halyard Health, Inc.. Device class: 2.

Clearance details

Applicant: Halyard Health, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2017-12-28
Decision date: 2018-01-26
Decision: Unknown
Clearance type: Special
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.