# K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Dec 18, 2007 after 134 days
- Product code: FAJ (Cystoscope 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: 7 generations back to K921244 (1992). 16 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040215: Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System, Vision-Sciences, Inc. (2004) Summary page 1.
- K053560: Modified Endosheath System for Vsi Flexible Cystoscope, Vision-Sciences, Inc. (2006) Summary page 1.

## Most influential descendants
- K160766: Ambu USR, Ambu M (2016), 14 descendants of its own
- K193095: Ambu aScope 4 Cysto (2020), 13 descendants of its own
- K181909: Luminelle DTx Hysteroscopy System (2018), 3 descendants of its own
- K190827: Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid (2019), 2 descendants of its own
- K222162: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (2022), 1 descendant of its own

## Indications for use
The flexible video cystoscope with EndoSheath® System is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures. The digital video processor is intended for use with the VSI flexible video scope.

Source page: https://510kreport.com/device/K072180
Methodology: https://510kreport.com/methodology