510(k) K201610
K201610 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "IonicRF Generator". The FDA issued a decision of Substantially Equivalent on October 21, 2020. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2020
- Date Received
- June 15, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Lesion, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 882.4400
- Review Panel
- NE
- Submission Type