# K251997: Single-Use Biopsy Valve (MAJ-1555)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 25, 2025 after 90 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- 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 K111821 (2011). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182275: Seal Single Use Biopsy Valve, Boston Scientific Corporation (2018) Summary page 6.

## Indications for use
The SINGLE USE BIOPSY VALVE MAJ-1555 has been designed to be attached to the instrument channel port of the endoscopes and to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.

Source page: https://510kreport.com/device/K251997
Methodology: https://510kreport.com/methodology