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510(k) K030578

BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM by Computer Motion, Inc. — Product Code NAY

K030578 is an FDA 510(k) premarket notification submitted by Computer Motion, Inc. for the device "BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 2003. The device falls under product code NAY (System, Surgical, Computer Controlled Instrument), 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
June 24, 2003
Date Received
February 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Surgical, Computer Controlled Instrument
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (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.

  • 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)
  • 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)

Other clearances for product code NAY

  • K261823 — da Vinci Surgical System, Model IS5000 (September 8, 2026)
  • K261824 — da Vinci Surgical System, Model IS5000 (July 31, 2026)
  • K260695 — da Vinci Firefly Imaging System (May 22, 2026)
  • K254192 — Senhance Ultrasonic System (May 12, 2026)
  • K253986 — da Vinci Force Feedback Instruments (March 11, 2026)
  • K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (January 16, 2026)
  • K251739 — da Vinci Surgical System (IS5000) (January 16, 2026)
  • K252675 — da Vinci SP Surgical System (SP1098) (December 15, 2025)
  • K252069 — da Vinci SP Surgical System (SP1098) (December 2, 2025)
  • K251426 — da Vinci SP Surgical System (SP1098) (October 3, 2025)

FDA data resources