BARD ENDOSCOPIC OVERTUBE (#000307)— 510(k) K973500

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K973500 for BARD ENDOSCOPIC OVERTUBE (#000307), Substantially Equivalent on 1997-10-16. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 1997-09-16
Decision date: 1997-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, 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.