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510(k) K003222

MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER by Computer Motion, Inc. — Product Code GCI

K003222 is an FDA 510(k) premarket notification submitted by Computer Motion, Inc. for the device "MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER". The FDA issued a decision of Substantially Equivalent on November 3, 2000. The device falls under product code GCI (Laryngoscope, Endoscope), a Class II device regulated under 21 CFR 876.1500. Computer Motion, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2000
Date Received
October 16, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Other clearances by Computer Motion, Inc.

  • K031956 — MODIFICATION TO HERMES O.R. CONTROL CENTER (July 17, 2003)
  • 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)

Other clearances for product code GCI

  • K021747 — DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (August 15, 2002)
  • K001362 — KARL STORZ 3D VIDEO SYSTEM (July 17, 2000)
  • K933515 — BOOTY ENDOSCOPE WARMER (October 27, 1993)
  • K930302 — BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)
  • K922123 — AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (February 1, 1993)
  • K920139 — GLEESON CLOT-BUSTER (April 15, 1992)
  • K915762 — POOLE TIP SUCTION PROBE (March 13, 1992)
  • K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (October 30, 1991)
  • K911829 — ENDOSTAPLE (August 28, 1991)

FDA data resources