K250263

Substantially Equivalent

Disposable Grasping Forceps FG-52D/FG-54D

Applicant: Olympus Medical Systems Corp.
Product code: KTI
Advisory panel: Ear, Nose, Throat
Date received: 2025-01-29
Decision date: 2025-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Adverse events under product code KTI

product code KTI

Malfunction: 642
Total: 642

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.