# K040604: Innervue Diagnostic Scope System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: Jun 4, 2004 after 88 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: 2 generations back to K932987 (1994). 3 ancestors in all.
31 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020310: Davlite Microendoscope & Accessories, Davlite Technologies (2002) Summary page 1.

## Most influential descendants
- K072879: Innervue Diagnostic Scope System (2008), 30 descendants of its own
- K082293: Surgview Integrated Visualization System (2008), 21 descendants of its own
- K093717: C-Mor Visualization Device (2010), 16 descendants of its own
- K141119: Camera Enabled Probe (2014), 7 descendants of its own
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), 7 descendants of its own

## Indications for use
This device is to be used by a trained physician for viewing the interior cavity of the human body through either a surgical or natural opening.

Source page: https://510kreport.com/device/K040604
Methodology: https://510kreport.com/methodology