# K014047: Applied Gelport Laparoscopic Hand Access Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Feb 28, 2002 after 83 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: 3 generations back to K954824 (1996). 4 ancestors in all.
4 later devices descend from it; 2 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)
- K990414: Smith & Nephew Handport System, Smith & Nephew, Inc. (1999) Summary page 1.
- K990663: Intromit Hand Access Port for Hand Assisted Laparoscopic Surgery, Model FP880-150, Medtech, Ltd. (1999) Summary page 1.

## Most influential descendants
- K090275: Gelport Single Incision Access System (2009), 3 descendants of its own
- 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
The Applied GelPort Laparoscopic Hand Access Device is indicated for use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by the surgeon’s hand and instrumentation. Additional slits may be made using a trocar at the periphery of the Gel Seal Cap to allow instrument access to the surgical site. The Applied GelPort Laparoscopic Hand Access 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/K014047
Methodology: https://510kreport.com/methodology