# K211234: RedEx

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Surgical Concepts, Ltd.
- Decided: Sep 17, 2021 after 147 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 RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation. Contraindications: RedEx is contraindicated for use with laparoscopic power and manual morcellators. RedEx is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

Source page: https://510kreport.com/device/K211234
Methodology: https://510kreport.com/methodology