# K904939: Flexible and Rigid Ureterotome System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Jan 7, 1992 after 432 days
- Product code: EZO (Urethrotome)
- Device class: 2
- Regulation: 21 CFR 876.4770
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K992141: Olympus Working Element for Probes (1999), 2 descendants of its own
- K050910: Roei Working Element and Roel Cutting Loops (2005), 1 descendant of its own
- K053322: Modification to: Roei Working Element and Roei Cutting Loops (2006), 0 descendants of its own
- K950719: Oes Urology (1996), 0 descendants of its own

## Recalls of this device
- Dec 22, 2010 · Not classified · Z-3102-2011: The device sterile package seal shows evidence of being breached or was breached

Source page: https://510kreport.com/device/K904939
Methodology: https://510kreport.com/methodology