# K042069: Invisio Irl Digital Rigid Laparoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: Nov 1, 2004 after 91 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: 5 generations back to K931154 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013165: Usa Series Laparoscopes, Circon Acmi (2002) Summary page 1.
- K030960: Ecn Electronic Video Cystonephroscope, Acmi Corporation (2003) Summary page 1.
- K955404: Otv-S5 Oes Video System, Olympus America, Inc. (1996) Summary page 1.

## Indications for use
The Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified physicians, to provide access to, illumination, and visualization of body cavities, during endoscopic laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K042069
Methodology: https://510kreport.com/methodology