# K261249: Universal Seal (5-12 mm)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 14, 2026 after 89 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: 7 generations back to K920110 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253978: Universal Seal (5-12 mm), Intuitive Surgical, Inc. (2026) Summary page 5.

## Indications for use
The da Vinci Trocar has applications in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K261249
Methodology: https://510kreport.com/methodology