Top Neuropole Needle, Model SH, BL, SC, TC
FDA 510(k) K080771 · Top Corp.
510(k) numberK080771
Submission
- Device name
- Top Neuropole Needle, Model SH, BL, SC, TC
- Applicant
- Top Corp.
Dunwoody, GA, US - Received
- March 19, 2008
- Decision date
- November 10, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Top Neuropole Needle, Model SH, BL, SC, TC cleared by the FDA?
Top Neuropole Needle, Model SH, BL, SC, TC (K080771) received a 510(k) decision of Substantially Equivalent on November 10, 2008, 236 days after the submission was received.
What is the product code of K080771?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.