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FDA 510(k)

SIRA™ RFA Electrosurgical Device

K-Number: K232947 · 2023-12-12

ApplicantInnoblative Designs, Inc.
Decision Date2023-12-12
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 2023-12-12 under approval number K232947. 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 2023-12-12. It is manufactured by Innoblative Designs, Inc.. The 510(k) number is K232947.

When was SIRA™ RFA Electrosurgical Device approved by the FDA?

SIRA™ RFA Electrosurgical Device received FDA 510(k) clearance on 2023-12-12, under approval number K232947.

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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