CARE + PLUS IRREGATION TRAY— 510(k) K863281

Substantially Equivalent

Welmed Systems, Inc.

FDA 510(k) clearance K863281 for CARE + PLUS IRREGATION TRAY, Substantially Equivalent on 1986-10-31. Applicant: Welmed Systems, Inc..

Clearance details

Applicant: Welmed Systems, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1986-08-25
Decision date: 1986-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Swanzey, NH, US

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.