510(k) K935255— ELDOR NEEDLE

Substantially Equivalent

Csen , Ltd.

Clearance details

Applicant: Csen , Ltd.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1993-11-01
Decision date: 1995-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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.