# K030174: Genicon Laparoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Genicon, LC
- Decided: Jun 19, 2003 after 153 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Surgical Image Laparoscope: named in the summary without a submission number

## Indications for use
The GeniCon Laparoscope is available in 3.5mm, 5mm and 10mm diameters with working lengths of 28cm to 44cm. This device has applications in gynecologic, general, thoracic and urology Endoscopic procedures to establish visualization for viewing an interior cavity of the body.

Source page: https://510kreport.com/device/K030174
Methodology: https://510kreport.com/methodology