# K041827: Dualflex RX Ercp Cannula, Models 4681, 4682

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 6, 2004 after 30 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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 K970054 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970054: Tandemrx, Boston Scientific Corp (1997) Summary page 1.

## Indications for use
Indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.

Source page: https://510kreport.com/device/K041827
Methodology: https://510kreport.com/methodology