# K944473: XCHF-33 Choledochofiberscope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Nov 22, 1995 after 439 days
- Product code: FBN (Choledochoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 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
- K051504: Spyscope Access and Delivery Catheter (2005), 11 descendants of its own
- K090170: Spyscope Access and Delivery Catheter (2009), 10 descendants of its own
- K142922: SpyGlass DS Direct Visualization System (2015), 9 descendants of its own
- K181439: SpyGlass DS and DS II Direct Visualization System (2018), 7 descendants of its own
- K183636: SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller (2019), 5 descendants of its own

Source page: https://510kreport.com/device/K944473
Methodology: https://510kreport.com/methodology