KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH— 510(k) K881667

Substantially Equivalent

The Kendal Co.

FDA 510(k) clearance K881667 for KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH, Substantially Equivalent on 1988-08-12. Applicant: The Kendal Co..

Clearance details

Applicant: The Kendal Co.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-18
Decision date: 1988-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.