SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)— 510(k) K061394

Name: FDA 510(k) clearance K061394
Creator: U.S. Food and Drug Administration
Published: 2006-09-06

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K061394 for SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE), Substantially Equivalent on 2006-09-06. Applicant: Busse Hospital Disposables, Inc.. Device class: 2.

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 2006-05-19
Decision date: 2006-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, 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.