FDA 510(k)

CryoThin™ 수술 시스템 및 액세서리

K-번호: K231661 · 2023-11-27

신청자Medinux (Tianjin) Technologies Co., Ltd.

결정일2023-11-27

제품 코드GEH

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

결정대체적으로 동일

기기 요약

CryoThin™ Surgical System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Medinux (Tianjin) Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K231661. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CryoThin™ Surgical System and Accessories?

CryoThin™ Surgical System and Accessories is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Medinux (Tianjin) Technologies Co., Ltd.. The 510(k) number is K231661.

When did CryoThin™ Surgical System and Accessories receive FDA 510(k) clearance?

CryoThin™ Surgical System and Accessories received FDA 510(k) clearance on 2023-11-27, under 510(k) number K231661.

Who is the listed applicant for CryoThin™ Surgical System and Accessories?

The FDA 510(k) record lists Medinux (Tianjin) Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryoThin™ Surgical System and Accessories?

The FDA product code for CryoThin™ Surgical System and Accessories is GEH.

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CryoThin™ 수술 시스템 및 액세서리

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEH)

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