FDA 510(k)

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories

K-번호: K192124 · 2019-11-21

결정일2019-11-21

제품 코드GEI

자문 위원회SU

결정Substantially Equivalent

기기 요약

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Innovations, LLC. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192124. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Us Medical Innovations, LLC. The 510(k) number is K192124.

When did Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories receive FDA 510(k) clearance?

Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192124.

Who is the listed applicant for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

The FDA 510(k) record lists Us Medical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories?

The FDA product code for Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories is GEI.

Us Medical Innovations, LLC를 신청인으로 등재한 기타 기록

K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)K212736Canady Flex RoboWrist

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