# K142427: Tissue Containment System; 10, 14, 17, 25

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Dec 23, 2014 after 116 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: 1 generation back to K910914 (1991). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060051: Specimen Retrieval System, Applied Medical Resources Corp. (2006) Summary page 4.
- K910914: Surgical Tissue Pouch, Cook Urological, Inc. (1991) Summary page 4.

## Most influential descendants
- K211043: Alexis Contained Extraction System (2022), 1 descendant of its own
- K211234: RedEx (2021), 1 descendant of its own
- K150781: Tissue Removal Pouch (2015), 1 descendant of its own
- K232701: Guardenia (GAR-1) (2023), 0 descendants of its own
- K151990: Tissue Removal System (2015), 0 descendants of its own

## Indications for use
The Applied Medical Tissue Containment System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. Contraindications: The Tissue Containment System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The Tissue Containment System 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/K142427
Methodology: https://510kreport.com/methodology