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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 the device name listed in this FDA 510(k) record. The listed applicant is Innoblative Designs, Inc.. It received FDA 510(k) clearance on 2023-12-12 under 510(k) 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. The listed applicant is Innoblative Designs, Inc.. The 510(k) number is K232947.

When did SIRA™ RFA Electrosurgical Device receive FDA 510(k) clearance?

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

Who is the listed applicant for SIRA™ RFA Electrosurgical Device?

The FDA 510(k) record lists Innoblative Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Innoblative Designs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181071SIRA RFA Electrosurgical Device

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Official Source

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