K111405

Substantially Equivalent

BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,

Applicant: Hangzhou Bever Medical Devices Co., Ltd.
Product code: GBM
Advisory panel: Gastroenterology, Urology
Date received: 2011-05-19
Decision date: 2012-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, Zhejiang, CN

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.