# K021152: Zeus Microwrist Robotic Surgical System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Computer Motion, Inc.
- Decided: Sep 24, 2002 after 167 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- 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 K930667 (1994). 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)
- K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System, Intuitive Surgical, Inc. (2000) Summary page 1.
- (no number) A standard laparoscope with hand-held minimally invasive surgical instruments: named in the summary without a submission number

## Indications for use
The ZEUS' MicroWristTMSurgical System (ZEUS System) and Accessories are intended to be used to assist a surgeon during procedures such as Laparoscopic Cholecystectomy and Nissen Fundoplication, to hold and position an endoscope, and to control laparoscopic instruments in performance of the surgical tasks of grasping, sharp cutting, blunt dissection, electro-cautery and suturing with knot placement. The ZEUS System is intended to be used by surgeons who are trained in minimally invasive surgery, have successfully completed a ZEUS System training program, and are certified in accordance with their respective hospital's customary practice for ZEUS System use. The ZEUS@ MicroWristTMSurgical System is intended to be used in an operating room environment in which the ZEUS System, the operating surgeon and patient are in the same room.

Source page: https://510kreport.com/device/K021152
Methodology: https://510kreport.com/methodology