# K251490: 8 mm Assist Cannula; 12 mm Assist Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 2, 2025 after 49 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: 15 generations back to K930667 (1994). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142683: 12 mm Endoscopes and Accessories, Intuitive Surgical, Inc. (2014) Summary page 5.

## Indications for use
The cannulas, obturators, seals, and related accessories are intended to establish a port of entry for instruments, endoscopes, or accessories. They are intended to be used only in a medical facility by trained medical professionals in accordance with its associated user manual.

Source page: https://510kreport.com/device/K251490
Methodology: https://510kreport.com/methodology