# K070947: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe Grasper

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Feb 14, 2008 after 316 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). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 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 2.
- K002489: Intuitive Surgical DA Vinci Endoscopic Control System, Intuitive Surgical, Inc. (2001) Summary page 2.
- K011002: Intuitive Surgical DA Vinci Surgical System, Model Isi 1000, Intuitive Surgical, Inc. (2001)
- K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family, Intuitive Surgical, Inc. (2002) Summary page 2.
- K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000, Intuitive Surgical, Inc. (2002) Summary page 2.
- K022574: Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model DA Vinci Isi 1000/1200, Intuitive Surgical, Inc. (2002) Summary page 2.
- K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments, Intuitive Surgical, Inc. (2004) Summary page 2.
- K043288: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 2.
- K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 2.
- K050369: Intuitive Surgical DA Vinci Surgical System, Model IS2000, Intuitive Surgical, Inc. (2005) Summary page 2.
- K050802: Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Intuitive Surgical, Inc. (2005) Summary page 2.
- K063220: DA Vinci S Surgical System-V1.1, Model IS2000, Intuitive Surgical, Inc. (2006) Summary page 2.
- K062140: Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1, Cryocath Technologies, Inc. (2006) Summary page 2.
- K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console, Cryocath Technologies, Inc. (2006) Summary page 2.
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console, Cryocath Technologies, Inc. (2004) Summary page 2.

## Cited in the summary but kept off the family tree
- K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000, Intuitive Surgical, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Apr 18, 2008 · Not classified · Z-1811-2008: The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument

## 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, ultrasonic shears, 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and 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. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.

Source page: https://510kreport.com/device/K070947
Methodology: https://510kreport.com/methodology