FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
K Number: K022100
·
Decision Sep 25, 2002
Classifications
1
FEI Numbers
246
Registration Numbers
246
Same Product Code
417
Applicant Total
22
Review Days
89
Basic Information
- Device Name
- NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
- K Number
- K022100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- IMAGE-GUIDED NEUROLOGICS, INC.
- Date Received
- June 28, 2002
- Decision Date
- September 25, 2002
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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|---|---|---|---|
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| K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | Oct 4, 2004 | Substantially Equivalent |
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| K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | Mar 2, 2004 | Substantially Equivalent |
| K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | Aug 21, 2003 | Substantially Equivalent |
| K024201 | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 | Mar 12, 2003 | Substantially Equivalent |
| K023949 | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | Feb 25, 2003 | Substantially Equivalent |
| K012719 | NAVIGUS II MR | Oct 22, 2001 | Substantially Equivalent |
| K012366 | NAVIGUS II TRAJECTORY GUIDE | Oct 1, 2001 | Substantially Equivalent |