# K132776: Seal Biopsy Valve - Reusable

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Dec 20, 2013 after 106 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 2.

## Indications for use
The device is intended to provide access for endoscopic device passage and exchange, helps maintain Insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K132776
Methodology: https://510kreport.com/methodology