# K202583: BioShield biopsy valve EUS - Linear

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Nov 6, 2020 after 59 days
- Product code: ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula)
- 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 K070420 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070420: Bioshield-Ercp Biopsy Valve, Model 00711138, United States Endoscopy Group, Inc. (2007) Summary page 5.

## Most influential descendants
- K233752: Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps (2024), 0 descendants of its own

## Indications for use
The single use BioShield@ biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. It provides 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/K202583
Methodology: https://510kreport.com/methodology