FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HERMES OPERATING ROOM CONTROL CENTER
K Number: K990691
·
Decision Mar 23, 1999
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
26
Review Days
20
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Basic Information
- Device Name
- HERMES OPERATING ROOM CONTROL CENTER
- K Number
- K990691
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Computer Motion, Inc.
- Date Received
- March 3, 1999
- Decision Date
- March 23, 1999
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Computer Motion, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031956 | MODIFICATION TO HERMES O.R. CONTROL CENTER | Jul 17, 2003 | Substantially Equivalent |
| K031720 | MODIFICATION TO HERMES O.R. CONTROL CENTER | Jul 11, 2003 | Substantially Equivalent |
| K031382 | MODIFICATION TO HERMES O.R. CONTROL CENTER | Jun 30, 2003 | Substantially Equivalent |
| K030578 | BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM | Jun 24, 2003 | Substantially Equivalent |
| K030718 | SCB COMPUTER MOTION INTERFACE CONTROLLER | Jun 5, 2003 | Substantially Equivalent |
| K030240 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | Feb 21, 2003 | Substantially Equivalent |
| K024294 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | Jan 8, 2003 | Substantially Equivalent |
| K023095 | HERMES OPERATING ROOM CONTROL CENTER | Nov 15, 2002 | Substantially Equivalent |
| K022897 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | Oct 11, 2002 | Substantially Equivalent |
| K021152 | ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES | Sep 24, 2002 | Substantially Equivalent |