Top Neuropole Needles, Models ST, X, RC, Xe and TL
FDA 510(k) K062946 · Top Corp.
510(k) numberK062946
Submission
- Device name
- Top Neuropole Needles, Models ST, X, RC, Xe and TL
- Applicant
- Top Corp.
Dunwoody, GA, US - Received
- September 28, 2006
- Decision date
- February 15, 2007
- 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 Needles, Models ST, X, RC, Xe and TL cleared by the FDA?
Top Neuropole Needles, Models ST, X, RC, Xe and TL (K062946) received a 510(k) decision of Substantially Equivalent on February 15, 2007, 140 days after the submission was received.
What is the product code of K062946?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.