UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle— 510(k) K142553

Substantially Equivalent

Unisis Corp.

FDA 510(k) clearance K142553 for UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle, Substantially Equivalent on 2015-01-14. Applicant: Unisis Corp..

Clearance details

Applicant: Unisis Corp.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2014-09-10
Decision date: 2015-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Koshigaya-Shi, JP

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.