FDA 510(k)

CUSA Clarity Ultrasonic Surgical Aspirator System

K-번호: K221763 · 2022-07-15

결정일2022-07-15

제품 코드LFL

결정Substantially Equivalent

기기 요약

CUSA Clarity Ultrasonic Surgical Aspirator System is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K221763. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CUSA Clarity Ultrasonic Surgical Aspirator System?

CUSA Clarity Ultrasonic Surgical Aspirator System is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K221763.

When did CUSA Clarity Ultrasonic Surgical Aspirator System receive FDA 510(k) clearance?

CUSA Clarity Ultrasonic Surgical Aspirator System received FDA 510(k) clearance on 2022-07-15, under 510(k) number K221763.

Who is the listed applicant for CUSA Clarity Ultrasonic Surgical Aspirator System?

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

What is the FDA product code for CUSA Clarity Ultrasonic Surgical Aspirator System?

The FDA product code for CUSA Clarity Ultrasonic Surgical Aspirator System is LFL.

Integra LifeSciences Corporation를 신청인으로 등재한 기타 기록

K251162CUSA® Clarity Ultrasonic Surgical Aspirator System K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)K240493CUSA® Clarity Ultrasonic Surgical Aspirator System K230427CUSA Clarity Ultrasonic Surgical Aspirator System K221835CUSA Clarity Ultrasonic Surgical Aspirator System K210128INTEGRA Wound Matrix (Macro-Channels)

28개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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