HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)— 510(k) K000723

Substantially Equivalent

Rochester Medical Corp.

FDA 510(k) clearance K000723 for HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC), Substantially Equivalent on 2000-05-19. Applicant: Rochester Medical Corp..

Clearance details

Applicant: Rochester Medical Corp.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2000-03-06
Decision date: 2000-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stewartville, MN, US

Download summary PDF View on FDA.gov ↗

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.