# K111002: Reprocessed Endoscopic Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Jul 18, 2011 after 98 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- 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: 4 generations back to K990028 (1999). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072674: Kii Trocar System, Applied Medical Resources Corp. (2007) Summary page 1.
- K060096: Modular Trocar System, Applied Medical Resources Corp. (2006) Summary page 1.
- K041795: Modification to Optical Separator System, Applied Medical Resources Corp. (2004) Summary page 1.
- K032889: Optical Separator, Applied Medical Resources (2003) Summary page 1.
- K012884: Dilating Tip Obturator, Applied Medical Resources Corp. (2002) Summary page 1.
- K012968: Applied Access Seal, Applied Medical Resources Corp. (2001) Summary page 1.

## Indications for use
The reprocessed endoscopic trocars; are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.

Source page: https://510kreport.com/device/K111002
Methodology: https://510kreport.com/methodology