FDA 510(k)

엔도가토르™ 하이브리드 이빙 튜브

K-번호: K231418 · 2023-08-14

결정일2023-08-14

제품 코드OCX

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

ENDOGATOR™ Hybrid Irrigation Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Medivators. It received FDA 510(k) clearance on 2023-08-14 under 510(k) number K231418. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ENDOGATOR™ Hybrid Irrigation Tubing?

ENDOGATOR™ Hybrid Irrigation Tubing is a medical device that received FDA 510(k) clearance on 2023-08-14. The listed applicant is Medivators. The 510(k) number is K231418.

When did ENDOGATOR™ Hybrid Irrigation Tubing receive FDA 510(k) clearance?

ENDOGATOR™ Hybrid Irrigation Tubing received FDA 510(k) clearance on 2023-08-14, under 510(k) number K231418.

Who is the listed applicant for ENDOGATOR™ Hybrid Irrigation Tubing?

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

What is the FDA product code for ENDOGATOR™ Hybrid Irrigation Tubing?

The FDA product code for ENDOGATOR™ Hybrid Irrigation Tubing is OCX.

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FDA 데이터베이스에서 보기 →

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

엔도가토르™ 하이브리드 이빙 튜브

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OCX)

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