Iontophoresis System
FDA 510(k) K073276 · Acclarent, Inc.
510(k) numberK073276
Submission
- Device name
- Iontophoresis System
- Applicant
- Acclarent, Inc.
Rmenlo Park, CA, US - Received
- November 21, 2007
- Decision date
- March 5, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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Questions and answers
When was Iontophoresis System cleared by the FDA?
Iontophoresis System (K073276) received a 510(k) decision of Substantially Equivalent on March 5, 2008, 105 days after the submission was received.
What is the product code of K073276?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.