FDA 510(k)

Dextera MicroCutter 30 블루 리로드, Dextera MicroCutter 30 커브드 터치 블루 리로드, Dextera MicroCutter 30 화이트 리로드, Dextera MicroCutter 30 커브드 터치 화이트 리로드

K-번호: K171561 · 2017-08-28

결정일2017-08-28

제품 코드GDW

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is the device name listed in this FDA 510(k) record. The listed applicant is Dextera Surgical, Inc.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K171561. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is Dextera Surgical, Inc.. The 510(k) number is K171561.

When did Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload receive FDA 510(k) clearance?

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload received FDA 510(k) clearance on 2017-08-28, under 510(k) number K171561.

Who is the listed applicant for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

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

What is the FDA product code for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

The FDA product code for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is GDW.

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Dextera MicroCutter 30 블루 리로드, Dextera MicroCutter 30 커브드 터치 블루 리로드, Dextera MicroCutter 30 화이트 리로드, Dextera MicroCutter 30 커브드 터치 화이트 리로드

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GDW)

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