# K053560: Modified Endosheath System for Vsi Flexible Cystoscope

- Pathway: 510(k) (Special)
- Applicant: Vision-Sciences, Inc.
- Decided: Mar 16, 2006 after 85 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: 6 generations back to K921244 (1992). 15 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 39 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.
- K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System, Vision-Sciences, Inc. (2003) Summary page 1.

## Most influential descendants
- K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System (2007), 20 descendants of its own
- K160766: Ambu USR, Ambu M (2016), 14 descendants of its own
- K193095: Ambu aScope 4 Cysto (2020), 13 descendants of its own
- K071127: Flexible Hysteroscope with Endosheath System (2007), 5 descendants of its own
- K181909: Luminelle DTx Hysteroscopy System (2018), 3 descendants of its own

## Indications for use
For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K053560
Methodology: https://510kreport.com/methodology