510(k) K910791— CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1991-02-25
Decision date: 1991-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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.