FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nitinol Thermocouple (TCN) Electrode
K Number: K183177
·
Decision Mar 8, 2019
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
231
Review Days
112
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Basic Information
- Device Name
- Nitinol Thermocouple (TCN) Electrode
- K Number
- K183177
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- November 16, 2018
- Decision Date
- March 8, 2019
- Product Code
- GXI
- 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 |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | FDA class 2 | Neurology |
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