Cadwell Guardian
FDA 510(k) K230415 · Cadwell Industries, Inc.
510(k) numberK230415
Submission
- Device name
- Cadwell Guardian
- Applicant
- Cadwell Industries, Inc.
Kennewick, WA, US - Received
- February 16, 2023
- Decision date
- August 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cadwell Guardian cleared by the FDA?
Cadwell Guardian (K230415) received a 510(k) decision of Substantially Equivalent on August 17, 2023, 182 days after the submission was received.
What is the product code of K230415?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.