FDA 510(k)

CURIS II RF 제어기 (REF 360100-05)

K-번호: K251813 · 2026-02-11

결정일2026-02-11

제품 코드GEI

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

결정Substantially Equivalent

기기 요약

CURIS II RF Generator (REF 360100-05) is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-02-11 under 510(k) number K251813. 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 CURIS II RF Generator (REF 360100-05)?

CURIS II RF Generator (REF 360100-05) is a medical device that received FDA 510(k) clearance on 2026-02-11. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K251813.

When did CURIS II RF Generator (REF 360100-05) receive FDA 510(k) clearance?

CURIS II RF Generator (REF 360100-05) received FDA 510(k) clearance on 2026-02-11, under 510(k) number K251813.

Who is the listed applicant for CURIS II RF Generator (REF 360100-05)?

The FDA 510(k) record lists Sutter Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURIS II RF Generator (REF 360100-05)?

The FDA product code for CURIS II RF Generator (REF 360100-05) is GEI.

Sutter Medizintechnik GmbH를 신청인으로 등재한 기타 기록

K233425FlexTip bipolar 전극 일회용 (AR-S9805-0028), FlexTip bipolar 전극 일회용 (AR-S9805-0035)K193587Sutter Swyng non-stick bipolar forceps, single-use K192128Sutter Arrowtip Monopolar Electrodes K191732Sutter RaVoR Bipolar Electrodes K171869Sutter CURIS RF 제너레이터

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