# K070021: Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0

- Pathway: 510(k) (Traditional)
- Applicant: Jg Medical Products, LLC
- Decided: Dec 7, 2007 after 338 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K962330 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894303: Medscope 4MM Arthroscope, Medscope Corp. (1989) Summary page 2.
- K031972: Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,, Asap Endoscopic Products GmbH (2003) Summary page 2.

## Most influential descendants
- K163037: Intra medullary endo-transilluminating device (iMET device) (2017), 0 descendants of its own

## Indications for use
The ITALITE Light Wand is indicated for illumination during joint examinations, arthroscopies, biopsies, in minimally invasive procedures of the knee, shoulder, temporal-mandibular joint, ankle, and elbow. The ITALITE Light Wand is disposable, single use and is intended to be discarded after the procedure. It is supplied clean but not sterile and must be sterilized before use. The ITALITE is for illumination only and is not indicated for viewing. It is to be used by physicians only.

Source page: https://510kreport.com/device/K070021
Methodology: https://510kreport.com/methodology