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FDA 510(k)

VIVACE Electrosurgical Device

K-Number: K193070 · 2021-04-26

ApplicantShenB Co., Ltd.
Decision Date2021-04-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIVACE Electrosurgical Device is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2021-04-26 under 510(k) number K193070. 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 VIVACE Electrosurgical Device?

VIVACE Electrosurgical Device is a medical device that received FDA 510(k) clearance on 2021-04-26. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K193070.

When did VIVACE Electrosurgical Device receive FDA 510(k) clearance?

VIVACE Electrosurgical Device received FDA 510(k) clearance on 2021-04-26, under 510(k) number K193070.

Who is the listed applicant for VIVACE Electrosurgical Device?

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

What is the FDA product code for VIVACE Electrosurgical Device?

The FDA product code for VIVACE Electrosurgical Device 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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