# K022595: Wilson-Cook Cystotome

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Oct 17, 2002 after 73 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 K970053 (1997). 4 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972674: Wilson-Cook Needle Knife Papillotome, Wilson-Cook Medical, Inc. (1997) Summary page 1.
- K013153: Autotome RX Model # 4515, 4516, Boston Scientific Corp (2001)
- K970278: Microvasive Gold Probe, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), 16 descendants of its own
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K150692: AXIOS Stent with Electrocautery Enhanced Delivery System (2015), 8 descendants of its own

## Indications for use
The Wilson-Cook Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Source page: https://510kreport.com/device/K022595
Methodology: https://510kreport.com/methodology