# K232162: Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Aug 14, 2023 after 24 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970053 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013153: Autotome RX Model # 4515, 4516, Boston Scientific Corp (2001) Summary page 4.

## Most influential descendants
- K260962: Sphincterotome (2026), 0 descendants of its own

## Indications for use
The Autotome Pro RX Sphincterotome is indicated for use in the selective cannulation of the Common Bile Ducts (CBD) and the transendoscopic sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. The Sphincterotome can also be used to inject contrast medium.

Source page: https://510kreport.com/device/K232162
Methodology: https://510kreport.com/methodology