PNEUMO-WEDGE— 510(k) K921143

Name: FDA 510(k) clearance K921143
Creator: U.S. Food and Drug Administration
Published: 1992-09-11

Substantially Equivalent

Kansas Creative Devices, Inc.

FDA 510(k) clearance K921143 for PNEUMO-WEDGE, Substantially Equivalent on 1992-09-11. Applicant: Kansas Creative Devices, Inc.. Device class: 1.

Clearance details

Applicant: Kansas Creative Devices, Inc.
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1992-03-11
Decision date: 1992-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laewood, KS, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.