K941672

Substantially Equivalent

URI-CATH CATHETER

Applicant: Gesco Intl., Inc.
Product code: GBM
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-05
Decision date: 1994-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.