# K243821: i-Cut

- Pathway: 510(k) (Traditional)
- Applicant: A.M.I. Agency For Medical Innovations GmbH
- Decided: Apr 25, 2025 after 134 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960640 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101458: Lina Xcise Model  Mor-1515, Lina Medical Aps (2011) Summary page 5.

## Indications for use
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.

Source page: https://510kreport.com/device/K243821
Methodology: https://510kreport.com/methodology