BUSSE EPIDURAL CATHETER KIT— 510(k) K093920

Name: FDA 510(k) clearance K093920
Creator: U.S. Food and Drug Administration
Published: 2010-08-06

Substantially Equivalent

Busse Hospital Disposables

FDA 510(k) clearance K093920 for BUSSE EPIDURAL CATHETER KIT, Substantially Equivalent on 2010-08-06. Applicant: Busse Hospital Disposables. Device class: 2.

Clearance details

Applicant: Busse Hospital Disposables
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 2009-12-22
Decision date: 2010-08-06
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 BSO

product code BSO

Malfunction: 688
Total: 688

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.