# K100346: Endoclear System

- Pathway: 510(k) (Special)
- Applicant: Virtual Ports, Ltd.
- Decided: Mar 10, 2010 after 26 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: 4 generations back to K955051 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080051: Virtual Ports Endoclear System, Virtual Ports, Ltd. (2008) Summary page 1.

## Indications for use
EndoClearTm Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.

Source page: https://510kreport.com/device/K100346
Methodology: https://510kreport.com/methodology