# K231358: Universal Seal (5-12 mm)

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 5, 2023 after 56 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 K920110 (1992). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181395: Universal Cannula Seal (5-12 mm), Intuitive Surgical, Inc. (2018) Summary page 4.

## Most influential descendants
- K241360: Universal Seal (5-12 mm) (2024), 2 descendants of its own
- K253978: Universal Seal (5-12 mm) (2026), 1 descendant of its own
- K261249: Universal Seal (5-12 mm) (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K231358
Methodology: https://510kreport.com/methodology