# K212500: ArtiSential Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Livsmed, Inc.
- Decided: Dec 3, 2021 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: 3 generations back to K990028 (1999). 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)
- K060096: Modular Trocar System, Applied Medical Resources Corp. (2006) Summary page 5.

## Indications for use
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K212500
Methodology: https://510kreport.com/methodology