K243894

Substantially Equivalent

F88 URE-SD/RD Flexible Ureteroscope

Applicant: Sg Endoscopy Pte, Ltd.
Product code: FGB
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-18
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N/A, SG

Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.