FDA 510(k)

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

K-번호: K252584 · 2026-06-25

결정일2026-06-25

제품 코드HIF

자문 위원회OB

결정Substantially Equivalent

기기 요약

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) is the device name listed in this FDA 510(k) record. The listed applicant is Weyo Surgical Technology , Ltd.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K252584. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)?

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Weyo Surgical Technology , Ltd.. The 510(k) number is K252584.

When did Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) receive FDA 510(k) clearance?

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K252584.

Who is the listed applicant for Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)?

The FDA 510(k) record lists Weyo Surgical Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)?

The FDA product code for Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) is HIF.

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Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: HIF)

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