IonicRF Generator
FDA 510(k) K201610 · Abbott Medical
510(k) numberK201610
Submission
- Device name
- IonicRF Generator
- Applicant
- Abbott Medical
Plymouth, MN, US - Received
- June 15, 2020
- Decision date
- October 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was IonicRF Generator cleared by the FDA?
IonicRF Generator (K201610) received a 510(k) decision of Substantially Equivalent on October 21, 2020, 128 days after the submission was received.
What is the product code of K201610?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.