# K033651: Olympus Video Ureteroscope, NTSC

- Pathway: 510(k) (Special)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jan 30, 2004 after 71 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
Longest line of descent: 1 generation back to K951855 (1995). 1 ancestor in all.
26 later devices descend from it; 2 cite it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951855: Ultrathin Ureteroscopes, Olympus America, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K233472: CVAC Aspiration System + CVAC Image Processor (2024), 3 descendants of its own

## Indications for use
This instrument has been designed to be used with an Olympus video system, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the urethra, bladder, and ureter.

Source page: https://510kreport.com/device/K033651
Methodology: https://510kreport.com/methodology