FDA 510(k)

파라곤 T2 워드와 통합 케이블

K-번호: K153675 · 2016-01-15

결정일2016-01-15

제품 코드GEI

자문 위원회SU

결정Substantially Equivalent

기기 요약

Paragon T2 Wand with Integrated Cable is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K153675. 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 Paragon T2 Wand with Integrated Cable?

Paragon T2 Wand with Integrated Cable is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is ArthroCare Corporation. The 510(k) number is K153675.

When did Paragon T2 Wand with Integrated Cable receive FDA 510(k) clearance?

Paragon T2 Wand with Integrated Cable received FDA 510(k) clearance on 2016-01-15, under 510(k) number K153675.

Who is the listed applicant for Paragon T2 Wand with Integrated Cable?

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

What is the FDA product code for Paragon T2 Wand with Integrated Cable?

The FDA product code for Paragon T2 Wand with Integrated Cable is GEI.

ArthroCare Corporation를 신청인으로 등재한 기타 기록

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