# K122203: Truetome

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 17, 2012 after 23 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). 3 ancestors in all.
No later device cites it as a predicate yet.
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 1.
- K930022: Sphincterotome, Boston Scientific Corp (1993) Summary page 1.

## Indications for use
The TRUEtomeTm Sphincterotome devices are indicated for use in transendoscopic spbincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The spbincterotome can also be used to cannulate and inject contrast medium.

Source page: https://510kreport.com/device/K122203
Methodology: https://510kreport.com/methodology