# K201355: Endomat Select, IBS Shaver Software, License

- Pathway: 510(k) (Special)
- Applicant: Karl Storz SE & CO. KG
- Decided: Jul 22, 2020 after 62 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: 8 generations back to K950035 (1996). 42 ancestors in all.
1 later device descends 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)
- K180735: Endomat Select, Karl Storz SE & CO. KG (2018) Summary page 4.
- K936231: The Karl Storz Hamou Endomat, Karl Storz Endoscopy (1995) Summary page 4.

## Most influential descendants
- 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 irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures provide the infusion of the sterile irrigant solutions into the uterus, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedures 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/K201355
Methodology: https://510kreport.com/methodology