K072354

Substantially Equivalent

GUIDEWIRE, MODEL G-V220-3527S AND OTHERS

Applicant: Accellent, Inc.
Product code: OCY
Advisory panel: Gastroenterology, Urology
Date received: 2007-08-22
Decision date: 2007-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.