# K210495: Port Access System

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Innovations Limited
- Decided: Jun 18, 2021 after 116 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: 3 generations back to K962193 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190592: YelloPort Elite Port Access System, Surgical Innovations Limited (2019) Summary page 4.

## Recalls of this device
- Mar 28, 2023 · Class II · Z-1601-2023: Optical Trocars sterility assurance can not be guaranteed
- Mar 28, 2023 · Class II · Z-1602-2023: Optical Trocars sterility assurance can not be guaranteed

## Indications for use
The Port Access System is indicated for use in laparoscopic procedures to give access to the abdominal and thoracic cavities while maintaining pneumoperitoneum.

Source page: https://510kreport.com/device/K210495
Methodology: https://510kreport.com/methodology