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Probe, Radiofrequency Lesion

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4725
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4725 Radiofrequency lesion probe

§ 882.4725 Radiofrequency lesion probe.

(a) Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

(b) Classification. Class II (performance standards).

Probe, Radiofrequency Lesion

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4725
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.4725 Radiofrequency lesion probe

§ 882.4725 Radiofrequency lesion probe.

(a) Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

(b) Classification. Class II (performance standards).