# K070420: Bioshield-Ercp Biopsy Valve, Model 00711138

- Pathway: 510(k) (Traditional)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Mar 19, 2007 after 27 days
- Product code: ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 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 no predicate by number.

## Most influential descendants
- K142068: Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating Adaptor, Sterile and Non-Sterile (2015), 8 descendants of its own
- K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (2021), 6 descendants of its own
- K232329: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter (2023), 3 descendants of its own
- K240352: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (2024), 1 descendant of its own
- K202583: BioShield biopsy valve EUS - Linear (2020), 1 descendant of its own

## Recalls of this device
- Oct 31, 2014 · Class II · Z-0861-2015: Packaging non-conformance related to the integrity of the sterile pouch seal.

## Indications for use
The single use BioShield® - ERCP biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K070420
Methodology: https://510kreport.com/methodology