# K982557: Bard Proforma and Apollo Pre-Curved Papillotomes

- Pathway: 510(k) (Traditional)
- Applicant: Bard Interventional Products Div.
- Decided: Sep 10, 1998 after 50 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.
1 later device descends from it; 1 cites it directly.
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 2.

## Most influential descendants
- K080946: Conmed Axcess Papillotome Models AX4535, AX4535FX (2008), 0 descendants of its own

## Indications for use
Bard papillotomes are designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi.

Source page: https://510kreport.com/device/K982557
Methodology: https://510kreport.com/methodology