# K002431: Elran 01 System

- Pathway: 510(k) (Abbreviated)
- Applicant: Envision Advanced Medical System, Ltd.
- Decided: Oct 24, 2000 after 77 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.
45 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K073279: VS-Visionsense Stereoscopic Vision System (2008), 44 descendants of its own
- K081102: Vsu - Visionsense Stereoscopic Vision System (2008), 42 descendants of its own
- K123467: VS3 (2013), 39 descendants of its own
- K131434: VS3 Stereoscopic High Definition Vision System (2013), 38 descendants of its own
- K082355: Visionsense Stereoscopic Vision System (2008), 37 descendants of its own

Source page: https://510kreport.com/device/K002431
Methodology: https://510kreport.com/methodology
