# K211043: Alexis Contained Extraction System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corporation
- Decided: Mar 31, 2022 after 357 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K910914 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142427: Tissue Containment System; 10, 14, 17, 25, Applied Medical Resources (2014) Summary page 4.

## Most influential descendants
- K232701: Guardenia (GAR-1) (2023), 0 descendants of its own

## Indications for use
The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.

Source page: https://510kreport.com/device/K211043
Methodology: https://510kreport.com/methodology