# K012578: Reprocessed Endoscopic Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Nov 7, 2001 after 90 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: 1 generation back to K925860 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922608: Endopath EP Disposable Trocar, ETHICON, Inc. (1993) Summary page 5.
- K925860: Modified Auto Suture Surgiport Premium Seal, United States Surgical, A Division of Tyco Healthc (1993) Summary page 5.

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

Source page: https://510kreport.com/device/K012578
Methodology: https://510kreport.com/methodology