STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML— 510(k) K132276

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K132276 for STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML, Substantially Equivalent on 2013-11-12. Applicant: Hospira, Inc..

Clearance details

Applicant: Hospira, Inc.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 2013-07-22
Decision date: 2013-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.