# K080946: Conmed Axcess Papillotome Models AX4535, AX4535FX

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Endoscopic Technologies, Inc.
- Decided: May 20, 2008 after 47 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 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)
- K982557: Bard Proforma and Apollo Pre-Curved Papillotomes, Bard Interventional Products Div. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K0113153: Boston Scientific Corporation Autotome. Number could not be read

## Indications for use
The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

Source page: https://510kreport.com/device/K080946
Methodology: https://510kreport.com/methodology