SCB COMPUTER MOTION INTERFACE CONTROLLER— 510(k) K030718
Substantially EquivalentComputer Motion, Inc.
FDA 510(k) clearance K030718 for SCB COMPUTER MOTION INTERFACE CONTROLLER, Substantially Equivalent on 2003-06-05. Applicant: Computer Motion, Inc.. Device class: 2.
Clearance details
- Applicant
- Computer Motion, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code GCJ
view allMore clearances from Computer Motion, Inc.
view all- K031956 — MODIFICATION TO HERMES O.R. CONTROL CENTER
- K031720 — MODIFICATION TO HERMES O.R. CONTROL CENTER
- K031382 — MODIFICATION TO HERMES O.R. CONTROL CENTER
- K030578 — BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
- K030240 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.