# K192300: EnlightenVue Microendoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Enlightenvue, Inc.
- Decided: Mar 20, 2020 after 210 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: 1 generation back to K981928 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981928: Galileo Disposable Endoscopes, Galileo Electro-Optics Corp. (1998) Summary page 4.

## Indications for use
The enlightenVue Microendoscopy System is intended for visualization of body cavities, hollow organs, and canals. The surgiVue microendoscope is designed to be introduced through natural body cavities or surgical incisions through introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter of the microendoscope.

Source page: https://510kreport.com/device/K192300
Methodology: https://510kreport.com/methodology