# K950729: Olympus PR-23Q Disposable Cannula (Ball Tip)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Mar 17, 1995 after 29 days
- Product code: ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 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
- K011149: Disposable Bending Cannula PR-233Q (2001), 12 descendants of its own
- 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

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0969-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Source page: https://510kreport.com/device/K950729
Methodology: https://510kreport.com/methodology