SILICONE ELASTOMER COATED LATEX FOLEY— 510(k) K810630

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K810630 for SILICONE ELASTOMER COATED LATEX FOLEY, Substantially Equivalent on 1981-03-31. Applicant: G.D. Searle and Co..

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1981-03-09
Decision date: 1981-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.