# K152663: Bladeless Optical Obturators

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Oct 16, 2015 after 29 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: 3 generations back to K920110 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133845: 8MM Trocar Kit, Intuitive Surgical (2014) Summary page 4.

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

Source page: https://510kreport.com/device/K152663
Methodology: https://510kreport.com/methodology