FDA 510(k)

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

K-번호: K190829 · 2019-12-19

신청자Wilson-Cook Medical Inc./Cook Endoscopy

결정일2019-12-19

제품 코드FBK

자문 위원회GU

결정Substantially Equivalent

기기 요약

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K190829. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K190829.

When did Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) receive FDA 510(k) clearance?

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) received FDA 510(k) clearance on 2019-12-19, under 510(k) number K190829.

Who is the listed applicant for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)?

The FDA product code for Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) is FBK.

Wilson-Cook Medical Inc./Cook Endoscopy를 신청인으로 등재한 기타 기록

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