ENDOSCOPIC OVERTUBE— 510(k) K833268

Substantially Equivalent

Mill-Rose Laboratory

FDA 510(k) clearance K833268 for ENDOSCOPIC OVERTUBE, Substantially Equivalent on 1983-10-31. Applicant: Mill-Rose Laboratory.

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 1983-09-21
Decision date: 1983-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.