Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit— 510(k) K151072

Substantially Equivalent

Solo-Dex, Inc.

FDA 510(k) clearance K151072 for Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit, Substantially Equivalent on 2016-01-22. Applicant: Solo-Dex, Inc..

Clearance details

Applicant: Solo-Dex, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2015-04-21
Decision date: 2016-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ladera Ranch, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.