K211436

Substantially Equivalent

Intermittent Catheter (Not Finalized)

Applicant: Hollister Incorporated
Product code: GBM
Advisory panel: Gastroenterology, Urology
Date received: 2021-05-10
Decision date: 2022-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, 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.