FDA 510(k)

Ureteral Access Sheath

K-번호: K250132 · 2025-09-05

신청자Zhejiang YiGao Medical Technology Co., Ltd.

결정일2025-09-05

제품 코드FED

자문 위원회GU

결정Substantially Equivalent

기기 요약

Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang YiGao Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250132. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Ureteral Access Sheath?

Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Zhejiang YiGao Medical Technology Co., Ltd.. The 510(k) number is K250132.

When did Ureteral Access Sheath receive FDA 510(k) clearance?

Ureteral Access Sheath received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250132.

Who is the listed applicant for Ureteral Access Sheath?

The FDA 510(k) record lists Zhejiang YiGao Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureteral Access Sheath?

The FDA product code for Ureteral Access Sheath is FED.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

Ureteral Access Sheath

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FED)

공식 출처