# K260856: Disposable Distal Attachment D-201-13404

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Aug 27, 2026 after 164 days
- Product code: FDS (Gastroscope 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: 4 generations back to K853585 (1986). 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)
- K250296: Disposable Distal Attachment D-201 Series, Olympus Medical Systems Corp. (2025) Summary page 5.

## Indications for use
The DISPOSABLE DISTAL ATTACHMENT D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract.

Source page: https://510kreport.com/device/K260856
Methodology: https://510kreport.com/methodology