WAK WEARABLE ARTIFICIAL KIDNEY— 510(k) K830291

Substantially Equivalent

Wak-Utah

FDA 510(k) clearance K830291 for WAK WEARABLE ARTIFICIAL KIDNEY, Substantially Equivalent on 1983-03-29. Applicant: Wak-Utah.

Clearance details

Applicant: Wak-Utah
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1983-01-27
Decision date: 1983-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.