CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK— 510(k) K993619

Substantially Equivalent

Sims Portex, Inc.

FDA 510(k) clearance K993619 for CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK, Substantially Equivalent on 2000-04-28. Applicant: Sims Portex, Inc..

Clearance details

Applicant: Sims Portex, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1999-10-26
Decision date: 2000-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

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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.