SPECTRUM SILICONE FOLEY CATHETER— 510(k) K000251

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K000251 for SPECTRUM SILICONE FOLEY CATHETER, Substantially Equivalent on 2000-08-30. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code MJC
Advisory panel: Gastroenterology, Urology
Date received: 2000-01-27
Decision date: 2000-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJC

product code MJC

Injury: 398
Malfunction: 12,582
Other: 2
Total: 12,982

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.