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FDA 510(k)

mJOULE RF System and Accessories

K-Number: K222958 · 2024-04-23

ApplicantSciton, Inc
Decision Date2024-04-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

mJOULE RF System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2024-04-23 under 510(k) number K222958. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mJOULE RF System and Accessories?

mJOULE RF System and Accessories is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is Sciton, Inc. The 510(k) number is K222958.

When did mJOULE RF System and Accessories receive FDA 510(k) clearance?

mJOULE RF System and Accessories received FDA 510(k) clearance on 2024-04-23, under 510(k) number K222958.

Who is the listed applicant for mJOULE RF System and Accessories?

The FDA 510(k) record lists Sciton, Inc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mJOULE RF System and Accessories?

The FDA product code for mJOULE RF System and Accessories is GEI.

Other records listing Sciton, Inc as applicant

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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.

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