SPIROL EPIDURAL CATHETER— 510(k) K000886

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K000886 for SPIROL EPIDURAL CATHETER, Substantially Equivalent on 2000-10-05. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2000-03-20
Decision date: 2000-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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.