Single Use Distal Cover MAJ-2315 (MAJ-2315)— 510(k) K253646
Substantially EquivalentOlympus 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.. Device class: 2.
Summary
Olympus Medical Systems' Single Use Distal Cover MAJ-2315 is filed under product code FDT (Duodenoscope And Accessories, Flexible/Rigid). The record doesn't describe the cover beyond its name and that code name.
Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Olympus filed from Hachioji-Shi, Japan. The decision came 94 calendar days after FDA received it (November 20, 2025 to February 22, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Product code FDT
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
Recent devices under product code FDT
view all- K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
- K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
- K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
- K233886 — Ambu® aScope Duodeno 2, Ambu® aBox 2
More clearances from Olympus Medical Systems Corp.
view all- K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB
- K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS) +2 more
- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
Adverse events under product code FDT
product code FDT- Death
- 86
- Injury
- 1,954
- Malfunction
- 14,912
- Total
- 16,952
Source: openFDA MAUDE database, through . 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.