DeviceClearance

Cadwell Guardian— 510(k) K230415

Substantially Equivalent

Cadwell Industries, Inc.

FDA 510(k) clearance K230415 for Cadwell Guardian, Substantially Equivalent on 2023-08-17. Applicant: Cadwell Industries, Inc.. Device class: 2.

Clearance details

Applicant
Cadwell Industries, Inc.
Product code
Code GWF
Device class
Class 2
Regulation
21 CFR 882.1870
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kennewick, WA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GWF

product code GWF
Malfunction
2,364
Other
4
Total
2,368

Source: openFDA MAUDE database, through . 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.