K143182

Substantially Equivalent

Speedicath Compact Male

Applicant: Coloplast A/S
Product code: GBM
Advisory panel: Gastroenterology, Urology
Date received: 2014-11-05
Decision date: 2015-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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.