# K072674: Kii Trocar System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Oct 5, 2007 after 14 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990028 (1999). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 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 1.
- K943489: Disposable Surgical Trocar, Applied Medical Resources (1994) Summary page 1.
- K971475: Shielded Surgical Trocar, Ethicon Endo-Surgery, Inc. (1997) Summary page 1.

## Most influential descendants
- K231400: Bladeless Trocar – Artemis Lap Cannula (2023), 0 descendants of its own
- K111002: Reprocessed Endoscopic Trocars (2011), 0 descendants of its own

## Recalls of this device
- May 4, 2017 · Class II · Z-2533-2017: Due to possibility of insufficient sterilization.
- Nov 5, 2012 · Class II · Z-0644-2013: Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield de

## Indications for use
The Applied Medical Modular Trocar System is a sterile, single-use device consisting of a bladed, shielded obturator, a cannula and seal. The obturator and seal may also be used with reusable APPLIED cannulas that may be made of stainless steel or DuraGold® polymer. The obturator is intended for use in conjunction with APPLIED'S currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Source page: https://510kreport.com/device/K072674
Methodology: https://510kreport.com/methodology