# K951855: Ultrathin Ureteroscopes

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Aug 16, 1995 after 117 days
- Product code: FGB (Ureteroscope 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.
28 later devices descend from it; 2 cite it directly.
1 of 29 devices in its family (counting itself) has 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
- K033651: Olympus Video Ureteroscope, NTSC (2004), 26 descendants of its own
- K153049: LithoVue System (2015), 24 descendants of its own
- K180367: Ureterorenoscope System (2018), 9 descendants of its own
- K221515: StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring (2023), 4 descendants of its own
- K201293: Ureterorenoscope System (2020), 4 descendants of its own

Source page: https://510kreport.com/device/K951855
Methodology: https://510kreport.com/methodology