BALLPEN SPINAL NEEDLE W/WO INTRODUCER— 510(k) K011122

Name: FDA 510(k) clearance K011122
Creator: U.S. Food and Drug Administration
Published: 2001-11-16

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K011122 for BALLPEN SPINAL NEEDLE W/WO INTRODUCER, Substantially Equivalent on 2001-11-16. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 2001-04-12
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jaffrey, NH, US

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.