K850268

Substantially Equivalent

SPARCO SCOPE GUARD

Applicant: Sparco, Inc.
Product code: FEB
Advisory panel: Gastroenterology, Urology
Date received: 1985-01-23
Decision date: 1985-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castro Valley, CA, US

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

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.