DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)— 510(k) K951928

Substantially Equivalent

Csen , Ltd.

FDA 510(k) clearance K951928 for DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE), Substantially Equivalent on 1997-05-30. Applicant: Csen , Ltd..

Clearance details

Applicant: Csen , Ltd.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1995-04-25
Decision date: 1997-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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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.