I-Endo Dual
FDA 510(k) K111623 · Satelec - Acteon Group
510(k) numberK111623
Submission
- Device name
- I-Endo Dual
- Applicant
- Satelec - Acteon Group
Mt. Laurel, NJ, US - Received
- June 10, 2011
- Decision date
- January 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was I-Endo Dual cleared by the FDA?
I-Endo Dual (K111623) received a 510(k) decision of Substantially Equivalent on January 10, 2012, 214 days after the submission was received.
What is the product code of K111623?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.