O'NEIL URINARY CATHETER INTRODUCER— 510(k) K854443

Substantially Equivalent

Pennine Medical , Ltd.

FDA 510(k) clearance K854443 for O'NEIL URINARY CATHETER INTRODUCER, Substantially Equivalent on 1986-01-08. Applicant: Pennine Medical , Ltd..

Clearance details

Applicant: Pennine Medical , Ltd.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1985-11-05
Decision date: 1986-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, 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.