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 a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2021-04-26 under approval 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. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K193070.
When was VIVACE Electrosurgical Device approved by the FDA?
VIVACE Electrosurgical Device received FDA 510(k) clearance on 2021-04-26, under approval number K193070.
What company makes VIVACE Electrosurgical Device?
VIVACE Electrosurgical Device is manufactured by ShenB Co., Ltd..
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
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