# K080291: Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist Stabilizer

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Mar 19, 2008 after 44 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: 10 generations back to K930667 (1994). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments, Intuitive Surgical, Inc. (2004) Summary page 1.
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000, Intuitive Surgical, Inc. (2005) Summary page 1.
- K060391: Intuitive Surgical Endowrist Stabilizer, Model 420182, Intuitive Surgical, Inc. (2006) Summary page 1.

## Recalls of this device
- Feb 16, 2015 · Class II · Z-1226-2015: There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterilit

## Indications for use
The Intuitive Surgical®Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical®Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the 4rth arm da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

Source page: https://510kreport.com/device/K080291
Methodology: https://510kreport.com/methodology