# K180735: Endomat Select

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Oct 31, 2018 after 223 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- 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 K950035 (1996). 41 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112642: Aquilex Fluid Control System H112, W.O.M. World of Medicine AG (2012). Our reading of the summary gave K112624, FDA’s number for Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4… (Roche Diagnostics). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “World of Medicine AQUILEX FLUID CONTROL SYSTEM H112”.
- K122619: Epix Irrigation Pump, Epix Suction Irrigation Tubing Set, Applied Medical (2012) Summary page 5.
- K042457: Uro Pro, W.O.M. World of Medicine AG (2004) Summary page 5.
- K031457: Endomat LC Pump, Model 20 3303 20, KARL STORZ Endoscopy-America, Inc. (2004) Summary page 5.
- K083707: Arthrex Dual Wave Arthroscopy Fluid Management Device, Arthrex, Inc. (2009) Summary page 5.
- K072410: Ksea Clearvision II, Model 40334120, KARL STORZ Endoscopy-America, Inc. (2008) Summary page 5.
- K013838: Ksea Clearvision Lens Irrigation System, KARL STORZ Endoscopy-America, Inc. (2002) Summary page 5.

## Most influential descendants
- 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
Endomat Select is intended to: provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures provide liquid distention of the uterus for diagnostic and operative hysteroscopy provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

Source page: https://510kreport.com/device/K180735
Methodology: https://510kreport.com/methodology