# K963484: Bard High Flow Papillotome

- Pathway: 510(k) (Traditional)
- Applicant: Bard Interventional Products Div.
- Decided: Nov 19, 1996 after 77 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 3.
- K930022: Sphincterotome, Boston Scientific Corp (1993) Summary page 3.

## Indications for use
The Bard High Flow papillotome is indicated for use in transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization.

Source page: https://510kreport.com/device/K963484
Methodology: https://510kreport.com/methodology