# K990376: Ballard Medical Products Faciletome Bow String Papillotome

- Pathway: 510(k) (Traditional)
- Applicant: Ballard Medical Products
- Decided: May 3, 1999 after 84 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: 1 generation back to K894861 (1989). 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)
- K894861: Wiltek Papillotome, Wiltek Medical, Inc. (1989) Summary page 1.

## Indications for use
The Ballard Medical Products® Faciletome™ Bow String Papillotome(s) is intended to be used for patients requiring transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

Source page: https://510kreport.com/device/K990376
Methodology: https://510kreport.com/methodology