# K202688: AFS Medical Sterile Single-Use Access Port System

- Pathway: 510(k) (Traditional)
- Applicant: Afs Medical Co., Ltd.
- Decided: Oct 14, 2021 after 394 days
- Product code: OTJ (Laparoscopic Single Port Access Device)
- 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: 5 generations back to K954824 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090275: Gelport Single Incision Access System, Applied Medical Resources Corp. (2009) Summary page 5.
- K014047: Applied Gelport Laparoscopic Hand Access Device, Applied Medical Resources Corp. (2002) Summary page 5.

## Indications for use
The AFS MEDICAL’s Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site

Source page: https://510kreport.com/device/K202688
Methodology: https://510kreport.com/methodology