# K162992: Karl Storz UROMAT E.A.S.I.

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Jul 7, 2017 after 253 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
Longest line of descent: 1 generation back to K981615 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981615: Ksea Uropump, KARL STORZ Endoscopy-America, Inc. (1998) Summary page 4.
- K010569: Ksea Universal Laparomat Laparoscopic Suction and Irrigation Pump, Karl Storz Endoscopy (2001) Summary page 4.

## Most influential descendants
- K213334: Monarch Platform, Urology (2022), 0 descendants of its own

## Indications for use
The UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.

Source page: https://510kreport.com/device/K162992
Methodology: https://510kreport.com/methodology
