BI-FLOW NEEDLE— 510(k) K761051

Substantially Equivalent

Dws, Inc.

FDA 510(k) clearance K761051 for BI-FLOW NEEDLE, Substantially Equivalent on 1976-12-30. Applicant: Dws, Inc..

Clearance details

Applicant: Dws, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1976-11-15
Decision date: 1976-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.