MODEL 5460 + 5480 POP-OFF VALVES— 510(k) K802591

Substantially Equivalent

G. Dundas Co.

FDA 510(k) clearance K802591 for MODEL 5460 + 5480 POP-OFF VALVES, Substantially Equivalent on 1980-11-12. Applicant: G. Dundas Co..

Clearance details

Applicant: G. Dundas Co.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 1980-10-21
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.