Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IonicRF Generator

K-Number: K201610 · 2020-10-21

Decision Date2020-10-21
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IonicRF Generator is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2020-10-21 under approval number K201610. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IonicRF Generator?

IonicRF Generator is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K201610.

When was IonicRF Generator approved by the FDA?

IonicRF Generator received FDA 510(k) clearance on 2020-10-21, under approval number K201610.

What company makes IonicRF Generator?

IonicRF Generator is manufactured by ABBOTT MEDICAL.

What is the FDA product code for IonicRF Generator?

The FDA product code for IonicRF Generator is GXD.

Other Devices by ABBOTT MEDICAL

View all 89 devices →

Related Devices (Code: GXD)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.