ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit— 510(k) K161232
Substantially EquivalentHalyard 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. Device class: 2.
Clearance details
- Applicant
- Halyard Health
- Product code
- Code BSO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5120
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
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Adverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
Source: openFDA MAUDE database, through . 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.