Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode
FDA 510(k) K100418 · Covidien
510(k) numberK100418
Submission
- Device name
- Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode
- Applicant
- Covidien
Mansfield, MA, US - Received
- February 16, 2010
- Decision date
- September 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode cleared by the FDA?
Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode (K100418) received a 510(k) decision of Substantially Equivalent on September 3, 2010, 199 days after the submission was received.
What is the product code of K100418?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.