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

Name: FDA 510(k) clearance K142553
Creator: U.S. Food and Drug Administration
Published: 2015-01-14

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.. Device class: 2.

Clearance details

Applicant: Unisis Corp.
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
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 ↗

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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.