# K260428: RIVOS™ EUS Access Device (M00553900)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 17, 2026 after 127 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- 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: 6 generations back to K935844 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A, Cook Ireland, Ltd. (2009) Summary page 6.
- K022595: Wilson-Cook Cystotome, Wilson-Cook Medical, Inc. (2002) Summary page 6.

## Indications for use
The device is used to access and electrosurgically puncture the transgastric or transduodenal wall into the following: the intra- or extrahepatic bile ducts, or a pancreatic pseudocyst. The device is intended for use through the accessory channel of an ultrasound endoscope.

Source page: https://510kreport.com/device/K260428
Methodology: https://510kreport.com/methodology