JUDD URETHAL CATHETER CONTAINER— 510(k) K864592

Substantially Equivalent

Phil Judd, Inc.

FDA 510(k) clearance K864592 for JUDD URETHAL CATHETER CONTAINER, Substantially Equivalent on 1987-06-24. Applicant: Phil Judd, Inc..

Clearance details

Applicant: Phil Judd, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1986-11-21
Decision date: 1987-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, 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.