# K261706: Endomat Select (UP220)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Jul 16, 2026 after 55 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: 9 generations back to K950035 (1996). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201355: Endomat Select, IBS Shaver Software, License, Karl Storz SE & CO. KG (2020) Summary page 5.

## Indications for use
Endomat Select is intended to: provide the infusion of the sterile irrigation solution into the ureter and upper urinary tract, as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures. provide the infusion of the sterile irrigation solution into the uterus, as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedure. provide the infusion of the sterile irrigation solution into organs and operating fields during diagnostic and operative endoscopic procedures in laparoscopic and open general surgery. provide sustained liquid irrigation and distention of joint or intra-articular spaces as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during all phases of arthroscopic surgery. provide the infusion of the sterile irrigation solution in order to enable cleaning of the lens during endoscopically assisted Functional Endoscopic Sinus Surgery.

Source page: https://510kreport.com/device/K261706
Methodology: https://510kreport.com/methodology