510(k) K143164— ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set

Substantially Equivalent

Kimberly-Clark Corporation

Clearance details

Applicant: Kimberly-Clark Corporation
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2014-11-03
Decision date: 2014-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.