Single Use Distal Cover MAJ-2315 (MAJ-2315)— 510(k) K253646

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K253646 for Single Use Distal Cover MAJ-2315 (MAJ-2315), Substantially Equivalent on 2026-02-22. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-20
Decision date: 2026-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.