# K090275: Gelport Single Incision Access System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Feb 18, 2009 after 14 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 K954824 (1996). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014047: Applied Gelport Laparoscopic Hand Access Device, Applied Medical Resources Corp. (2002) Summary page 1.

## Most influential descendants
- K202688: AFS Medical Sterile Single-Use Access Port System (2021), 0 descendants of its own
- K120898: Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar 8850XX Sealing CA (2012), 0 descendants of its own
- K100180: Surgiquest Anchorport Sil Kit (2010), 0 descendants of its own

## Indications for use
For use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by instrumentation. Trocars may be placed through the Gel Seal Cap to allow instrument access to the surgical site, The device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, urological and general surgery to access the surgical site.

Source page: https://510kreport.com/device/K090275
Methodology: https://510kreport.com/methodology