TWOFER NEEDLE— 510(k) K832347

Substantially Equivalent

Baxa Corp., Sub. of Cook Group, Inc.

FDA 510(k) clearance K832347 for TWOFER NEEDLE, Substantially Equivalent on 1983-09-12. Applicant: Baxa Corp., Sub. of Cook Group, Inc..

Clearance details

Applicant: Baxa Corp., Sub. of Cook Group, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1983-07-18
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.