# K111821: Biopsy Valve

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Jul 28, 2011 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
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) US Endloscopy - Bioshield - ERCP Biopsy Valve: named in the summary without a submission number

## Most influential descendants
- K133734: Seal Single-Use Biopsy Valve (2014), 4 descendants of its own
- K161167: Seal Single-Use Biopsy Valve (2016), 3 descendants of its own
- K182275: Seal Single Use Biopsy Valve (2018), 1 descendant of its own
- K152140: Boa Endoscopic Valve (2015), 1 descendant of its own
- K251997: Single-Use Biopsy Valve (MAJ-1555) (2025), 0 descendants of its own

## Indications for use
Biopsy valves are intended to provide access for endloscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomnaterial from the biopsy port throughout the endloscopic procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K111821
Methodology: https://510kreport.com/methodology