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FDA 510(k)

SIRA RFA Electrosurgical Device

K-Number: K181071 · 2019-01-16

ApplicantInnoblative Designs, Inc.
Decision Date2019-01-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIRA RFA Electrosurgical Device is a medical device manufactured by Innoblative Designs, Inc.. It received FDA 510(k) clearance on 2019-01-16 under approval number K181071. 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 SIRA RFA Electrosurgical Device?

SIRA RFA Electrosurgical Device is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Innoblative Designs, Inc.. The 510(k) number is K181071.

When was SIRA RFA Electrosurgical Device approved by the FDA?

SIRA RFA Electrosurgical Device received FDA 510(k) clearance on 2019-01-16, under approval number K181071.

What company makes SIRA RFA Electrosurgical Device?

SIRA RFA Electrosurgical Device is manufactured by Innoblative Designs, Inc..

What is the FDA product code for SIRA RFA Electrosurgical Device?

The FDA product code for SIRA RFA Electrosurgical Device is GEI.

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Official Source

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