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510(k) K031956

MODIFICATION TO HERMES O.R. CONTROL CENTER by Computer Motion, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2003
Date Received
June 25, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Computer Motion, Inc.

  • K031720 — MODIFICATION TO HERMES O.R. CONTROL CENTER (July 11, 2003)
  • K031382 — MODIFICATION TO HERMES O.R. CONTROL CENTER (June 30, 2003)
  • K030578 — BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM (June 24, 2003)
  • K030718 — SCB COMPUTER MOTION INTERFACE CONTROLLER (June 5, 2003)
  • K030240 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (February 21, 2003)
  • K024294 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (January 8, 2003)
  • K023095 — HERMES OPERATING ROOM CONTROL CENTER (November 15, 2002)
  • K022897 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (October 11, 2002)
  • K021152 — ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES (September 24, 2002)
  • K013551 — ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM (March 28, 2002)

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