# K232701: Guardenia (GAR-1)

- Pathway: 510(k) (Special)
- Applicant: Advanced Surgical Concepts
- Decided: Sep 29, 2023 after 24 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: 3 generations back to K910914 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211234: RedEx, Advanced Surgical Concepts, Ltd. (2021) Summary page 5.
- K211043: Alexis Contained Extraction System, Applied Medical Resources Corporation (2022) Summary page 5.

## Indications for use
The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation. Contraindications: Guardeniais contraindicated for use with laparoscopic power morcellators. Guardenia 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/K232701
Methodology: https://510kreport.com/methodology