# K101743: 5MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Feb 4, 2011 after 227 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930667 (1994). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 1.

## Most influential descendants
- K123329: DA Vinvi Surgical System (2014), 3 descendants of its own
- K210478: 8mm Monopolar Curved Scissors (2022), 0 descendants of its own
- K173415: EndoWrist 5mm Thoracic Grasper (2018), 0 descendants of its own
- K170641: da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes (2017), 0 descendants of its own

## Recalls of this device
- May 6, 2013 · Class II · Z-1463-2013: Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

## Indications for use
The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.

Source page: https://510kreport.com/device/K101743
Methodology: https://510kreport.com/methodology