# K060534: Intuitive Surgical Seal

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Resources Corp.
- Decided: Mar 13, 2006 after 13 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: 1 generation back to K932995 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932995: Surgical Trocar and Cannula, Applied Medical Resources (1993) Summary page 1.

## Indications for use
The Intuitive Surgical Seal is Indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments

Source page: https://510kreport.com/device/K060534
Methodology: https://510kreport.com/methodology