GEENEN/ZEBRA GUIDELINES— 510(k) K942677

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K942677 for GEENEN/ZEBRA GUIDELINES, Substantially Equivalent on 1994-07-21. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code FDE
Advisory panel: Gastroenterology, Urology
Date received: 1994-06-07
Decision date: 1994-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

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Adverse events under product code FDE

product code FDE

Other: 1
Total: 1

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.