# K011149: Disposable Bending Cannula PR-233Q

- Pathway: 510(k) (Special)
- Applicant: The Olympus Optical Co.
- Decided: May 15, 2001 after 29 days
- Product code: ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula)
- 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: 1 generation back to K950166 (1995). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950729: Olympus PR-23Q Disposable Cannula (Ball Tip), Olympus America, Inc. (1995) Summary page 4.
- K950166: Olympus KD-6G1-9Q Wire Guided Papillotomu Knife, Olympus America, Inc. (1995) Summary page 4.

## 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

## Indications for use
This instrument has been designed to be used with an Olympus endoscope to inject contrast medium in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.

Source page: https://510kreport.com/device/K011149
Methodology: https://510kreport.com/methodology