ON-Q* Pump with Bolus— 510(k) K181360

Substantially Equivalent

Halyard Health

FDA 510(k) clearance K181360 for ON-Q* Pump with Bolus, Substantially Equivalent on 2019-03-22. Applicant: Halyard Health.

Clearance details

Applicant: Halyard Health
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2018-05-22
Decision date: 2019-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.