FDA 510(k)

CUSA Clarity Ultrasonic Surgical Aspirator System

K-번호: K230427 · 2023-07-11

결정일2023-07-11

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 2023-07-11 under 510(k) number K230427. 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 2023-07-11. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K230427.

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 2023-07-11, under 510(k) number K230427.

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 K221835CUSA Clarity Ultrasonic Surgical Aspirator System K221763CUSA Clarity Ultrasonic Surgical Aspirator System K210128INTEGRA Wound Matrix (Macro-Channels)

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