# K101095: Direct Peroral Cholangioscopy Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jul 19, 2010 after 90 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953951 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063677: Fusion Quattro Extraction Balloon XL, Wilson-Cook Medical, Inc. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K090117: Autosafe-Reflex Safety Huber Infusion Set, Autosafe Advantage Safety Huber Infusion Set, Autosafe-Reflex, Inc. (2009). Our reading of the summary gave K090117, FDA’s number for Autosafe-Reflex Safety Huber Infusion Set, Autosafe… (Autosafe-Reflex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SpyScope Access and Delivery Catheter”. Kept off the family tree. Summary page 1.

## Recalls of this device
- Dec 23, 2010 · Not classified · Z-0925-2011: Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.
- Dec 23, 2010 · Not classified · Z-0926-2011: There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty, resulting in poor patient outcomes.

## Indications for use
This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.

Source page: https://510kreport.com/device/K101095
Methodology: https://510kreport.com/methodology