# K182275: Seal Single Use Biopsy Valve

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Sep 13, 2018 after 22 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: 3 generations back to K111821 (2011). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161167: Seal Single-Use Biopsy Valve, Endochoice, Inc. (2016) Summary page 4.

## Most influential descendants
- K251997: Single-Use Biopsy Valve (MAJ-1555) (2025), 0 descendants of its own

## Indications for use
The Seal Single Use Biopsy Valve is intended 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/K182275
Methodology: https://510kreport.com/methodology