# K013804: Socrates Robotic Telemonitoring System

- Pathway: 510(k) (Special)
- Applicant: Computer Motion, Inc.
- Decided: Dec 10, 2001 after 25 days
- Product code: NEQ (Device, Telemedicine, Robotic)
- 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: 1 generation back to K003661 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003661: Socrates Robotic Telemonitoring System, Computer Motion, Inc. (2001) Summary page 1.

## Indications for use
The SOCRATES System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, €ar endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafiing where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. Use of the SOCRATES System enables a remote surgeon [0 telecommunicate with any AESOP HR Jocal controller through HERMES. This communication link allows the remote surgeon 1o assist the local surgeon with field-of-view positioning. The users of the SOCRATES System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Source page: https://510kreport.com/device/K013804
Methodology: https://510kreport.com/methodology