# K990414: Smith & Nephew Handport System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 14, 1999 after 63 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: 2 generations back to K954824 (1996). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962147: Dexterity Pneumo Sleeve Set, Medical Creative Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K014047: Applied Gelport Laparoscopic Hand Access Device (2002), 4 descendants of its own
- 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 Smith & Nephew HandPort System is indicated for use in laparoscopic procedures, where entry of the surgeon’s hand may facilitate the procedure, and for extraction of large specimens.

Source page: https://510kreport.com/device/K990414
Methodology: https://510kreport.com/methodology