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FDA 510(k)

SERF ABLATION SYSTEM SERF ABLATION NEEDLE

K-Number: K120116 · 2012-10-01

ApplicantThermedical
Decision Date2012-10-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SERF ABLATION SYSTEM SERF ABLATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Thermedical. It received FDA 510(k) clearance on 2012-10-01 under 510(k) number K120116. 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 SERF ABLATION SYSTEM SERF ABLATION NEEDLE?

SERF ABLATION SYSTEM SERF ABLATION NEEDLE is a medical device that received FDA 510(k) clearance on 2012-10-01. The listed applicant is Thermedical. The 510(k) number is K120116.

When did SERF ABLATION SYSTEM SERF ABLATION NEEDLE receive FDA 510(k) clearance?

SERF ABLATION SYSTEM SERF ABLATION NEEDLE received FDA 510(k) clearance on 2012-10-01, under 510(k) number K120116.

Who is the listed applicant for SERF ABLATION SYSTEM SERF ABLATION NEEDLE?

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

What is the FDA product code for SERF ABLATION SYSTEM SERF ABLATION NEEDLE?

The FDA product code for SERF ABLATION SYSTEM SERF ABLATION NEEDLE is GEI.

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Official Source

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