510(k) K992471— SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18

Substantially Equivalent

Sims Portex, Inc.

Clearance details

Applicant: Sims Portex, Inc.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 1999-07-26
Decision date: 1999-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

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.