# K010993: Alien RX Micro Cannula, Model 4530

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 30, 2001 after 27 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 K833417 (1983). 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)
- K833417: Endoscopic Retrograde, Microvasive (1983) Summary page 4.

## Indications for use
The Alien™ RX Micro Cannula is indicated for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram.

Source page: https://510kreport.com/device/K010993
Methodology: https://510kreport.com/methodology