# K122417: Scopevalet Disposable Biopsy Valve

- Pathway: 510(k) (Traditional)
- Applicant: The Ruhof Corp.
- Decided: May 17, 2013 after 282 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: 1 generation back to K111821 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111821: Biopsy Valve, Endochoice, Inc. (2011) Summary page 1.

## Indications for use
The Scopevalet Disposable Biopsy Valves, Model Numbers 34S8VO and 34SBVP, are intended to provide access for endloscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endloscopic procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K122417
Methodology: https://510kreport.com/methodology