ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit— 510(k) K161232

Substantially Equivalent

Halyard Health

FDA 510(k) clearance K161232 for ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit, Substantially Equivalent on 2016-09-30. Applicant: Halyard Health.

Clearance details

Applicant: Halyard Health
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2016-05-02
Decision date: 2016-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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.