# K901443: Zimmon Papillotome

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 18, 1990 after 83 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033203: Wilson-Cook Tri-Tome Select Plus (2003), 6 descendants of its own
- K172665: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords (2018), 4 descendants of its own
- K052051: Omni Sphincterotome (2005), 4 descendants of its own
- K172288: Fusion OMNI Sphincterotome (2018), 3 descendants of its own
- K201121: Sphincterotome (2021), 2 descendants of its own

## Recalls of this device
- Dec 17, 2003 · Not classified · Z-0301-04: Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.

Source page: https://510kreport.com/device/K901443
Methodology: https://510kreport.com/methodology