FDA 510(k)

LevaLap 레이저 내시경 접근 장치

K-번호: K212786 · 2022-02-23

신청자Core Access Surgical Technologies, Inc.

결정일2022-02-23

제품 코드HIF

자문 위원회OB

결정Substantially Equivalent

기기 요약

LevaLap Laparoscopic Access Device is the device name listed in this FDA 510(k) record. The listed applicant is Core Access Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K212786. 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 LevaLap Laparoscopic Access Device?

LevaLap Laparoscopic Access Device is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Core Access Surgical Technologies, Inc.. The 510(k) number is K212786.

When did LevaLap Laparoscopic Access Device receive FDA 510(k) clearance?

LevaLap Laparoscopic Access Device received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212786.

Who is the listed applicant for LevaLap Laparoscopic Access Device?

The FDA 510(k) record lists Core Access Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LevaLap Laparoscopic Access Device?

The FDA product code for LevaLap Laparoscopic Access Device is HIF.

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FDA 데이터베이스에서 보기 →

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

LevaLap 레이저 내시경 접근 장치

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: HIF)

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