# K253646: Single Use Distal Cover MAJ-2315 (MAJ-2315)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Feb 22, 2026 after 94 days
- Product code: FDT (Duodenoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K080403 (2008). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220587: Evis Exera III Duodenovideoscope Olympus TJF-Q190V, Olympus Medical Systems Corp. (2022) Summary page 5.

## Indications for use
The SINGLE USE DISTAL COVER MAJ-2315 has been designed to be attached to OLYMPUS endoscopes to cover the distal end of the insertion tube and around the forceps elevator.

Source page: https://510kreport.com/device/K253646
Methodology: https://510kreport.com/methodology