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510(k) Data Aggregation
K Number
K013804Device Name
SOCRATES ROBOTIC TELEMONITORING SYSTEM
Manufacturer
COMPUTER MOTION, INC.
Date Cleared
2001-12-10
(25 days)
Product Code
NEQ
Regulation Number
876.1500Why did this record match?
Product Code :
NEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOCRATES System is indicated for use in general cardiothoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy, and sinuscopy where a general laparoscope/endoscope is indicated for use. A few example indications 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 grafting 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 to telecommunicate with any AESOP™ Robotic System and assist the local surgeon with field-of-view positioning.
Device Description
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K Number
K003661Device Name
SOCRATES ROBOTIC TELEMONITORING SYSTEM
Manufacturer
COMPUTER MOTION, INC.
Date Cleared
2001-10-05
(311 days)
Product Code
NEQ
Regulation Number
876.1500Why did this record match?
Product Code :
NEQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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