FDA 510(k)

SIRA™ RFA 전기수술 장비

K-번호: K232947 · 2023-12-12

결정일2023-12-12

제품 코드GEI

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Innoblative Designs, Inc.를 신청인으로 등재한 기타 기록

K181071시라 RFA 전기수술 장비

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