# K232951: BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)

- Pathway: 510(k) (Special)
- Applicant: Steris
- Decided: Oct 20, 2023 after 29 days
- Product code: ODC (Endoscope Channel Accessory)
- 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 K070420 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210342: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor, STERIS Corporation (2021) Summary page 6.

## Indications for use
The single-use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufllation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation. The BioShield lrrigator - extension tubing is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield lrrigator. The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.

Source page: https://510kreport.com/device/K232951
Methodology: https://510kreport.com/methodology