FDA 510(k)

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)

K-번호: K252412 · 2025-10-31

신청자Applied Medical Resources Corporation

결정일2025-10-31

제품 코드GEI

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

결정대체적으로 동일

기기 요약

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252412. 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 Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K252412.

When did Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) receive FDA 510(k) clearance?

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252412.

Who is the listed applicant for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

The FDA product code for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is GEI.

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