# K161167: Seal Single-Use Biopsy Valve

- Pathway: 510(k) (Special)
- Applicant: Endochoice, Inc.
- Decided: May 26, 2016 after 30 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: 2 generations back to K111821 (2011). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133734: Seal Single-Use Biopsy Valve, Endochoice, Inc. (2014) Summary page 5.

## Most influential descendants
- K182275: Seal Single Use Biopsy Valve (2018), 1 descendant of its own
- K251997: Single-Use Biopsy Valve (MAJ-1555) (2025), 0 descendants of its own
- K173758: Disposable Biopsy Valve (2018), 0 descendants of its own

## Indications for use
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K161167
Methodology: https://510kreport.com/methodology