FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBDURAL STRIP ELECTRODE
K Number: K021144
·
Decision Jun 24, 2002
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
31
Applicant Total
10
Review Days
76
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Basic Information
- Device Name
- SUBDURAL STRIP ELECTRODE
- K Number
- K021144
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.1310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nicolet Biomedical, Inc.
- Date Received
- April 9, 2002
- Decision Date
- June 24, 2002
- Product Code
- GYC
- 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 |
|---|---|---|---|
| GYC | Electrode, Cortical | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GYC), ordered by most recent decision date.
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
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FDA Class 2
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Layer 7-T
FDA 510(k)
FDA Class 2
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WISE Cortical Strip (WCS)
FDA 510(k)
FDA Class 2
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Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
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FDA Class 2
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Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
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Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Nicolet Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021986 | BRAINET | Aug 23, 2002 | Substantially Equivalent |
| K020218 | SNAP EEG MONITOR | Apr 22, 2002 | Substantially Equivalent |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | Apr 17, 2002 | Substantially Equivalent |
| K011818 | STERILE EMG ELECTRODES | Sep 6, 2001 | Substantially Equivalent |
| K011823 | BIOREHAB SYSTEM | Sep 6, 2001 | Substantially Equivalent |
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES | Mar 19, 2001 | Substantially Equivalent |
| K991054 | BRAVO MULTI-MODALITY SYSTEM | Nov 3, 1999 | Substantially Equivalent |
| K971331 | SATELLITE | Jun 25, 1997 | Substantially Equivalent |
| K950270 | NMI SOFTWARE | May 15, 1995 | Substantially Equivalent |