# K221365: LapBox Tissue Containment Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Ark Surgical, Ltd.
- Decided: Aug 25, 2022 after 105 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K090317: Babi*Plus Bubble Pap Valve, A Plus Medical (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The LapBox Tissue Containment Removal System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. Contraindications: The LapBox Tissue Containment Removal System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The LapBox Containment Removal 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/K221365
Methodology: https://510kreport.com/methodology