# K051504: Spyscope Access and Delivery Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jun 16, 2005 after 9 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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
Longest line of descent: 2 generations back to K950166 (1995). 4 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011149: Disposable Bending Cannula PR-233Q, The Olympus Optical Co. (2001)
- K944473: XCHF-33 Choledochofiberscope, Olympus America, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K200483: SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller (2020), 3 descendants of its own

## Indications for use
The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the biliary system including the hepatic ducts.

Source page: https://510kreport.com/device/K051504
Methodology: https://510kreport.com/methodology