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FDA 510(k)

EUSRA RF Electrode

K-Number: K181249 · 2018-09-04

ApplicantStarmed Co., Ltd.
Decision Date2018-09-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EUSRA RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2018-09-04 under 510(k) number K181249. 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 EUSRA RF Electrode?

EUSRA RF Electrode is a medical device that received FDA 510(k) clearance on 2018-09-04. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K181249.

When did EUSRA RF Electrode receive FDA 510(k) clearance?

EUSRA RF Electrode received FDA 510(k) clearance on 2018-09-04, under 510(k) number K181249.

Who is the listed applicant for EUSRA RF Electrode?

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

What is the FDA product code for EUSRA RF Electrode?

The FDA product code for EUSRA RF Electrode is GEI.

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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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