# K190592: YelloPort Elite Port Access System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Innovations Limited
- Decided: Apr 29, 2019 after 53 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962193 (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)
- K070712: Modification to: Yelloport Port Access System, Surgical Innovations Group Plc (2007) Summary page 6.
- K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar, Ethicon Endo-Surgery, Inc. (2003) Summary page 6.

## Most influential descendants
- K210495: Port Access System (2021), 0 descendants of its own

## Recalls of this device
- Jun 2, 2022 · Class II · Z-1396-2022: There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
- Jan 20, 2022 · Class II · Z-1852-2022: Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

## Indications for use
The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum. The YelloPort Elite port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.

Source page: https://510kreport.com/device/K190592
Methodology: https://510kreport.com/methodology