TUOHY EPIDURAL NEEDLES— 510(k) K961152

Substantially Equivalent

Hakko Shoji Co., Ltd.

FDA 510(k) clearance K961152 for TUOHY EPIDURAL NEEDLES, Substantially Equivalent on 1997-03-19. Applicant: Hakko Shoji Co., Ltd..

Clearance details

Applicant: Hakko Shoji Co., Ltd.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1996-03-22
Decision date: 1997-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.