# K980808: Endo FMS Urology

- Pathway: 510(k) (Traditional)
- Applicant: Future Medical Systems, Inc.
- Decided: May 8, 1998 after 66 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- 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; 1 cites 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042457: Uro Pro (2004), 3 descendants of its own
- K180735: Endomat Select (2018), 2 descendants of its own
- K201355: Endomat Select, IBS Shaver Software, License (2020), 1 descendant of its own
- K261706: Endomat Select (UP220) (2026), 0 descendants of its own

## Indications for use
The ENDO FMS® UROLOGY is a fluid management system used to maintain adequate irrigation pressure and flow in endoscopic Urology procedures, including all endoscopic procedures in the Kidney, Ureter/Urethra, Bladder and Prostate.

Source page: https://510kreport.com/device/K980808
Methodology: https://510kreport.com/methodology