FDA 510(k)

GIA Auto Suture Stapler with DST Series Technology

K-번호: K221013 · 2022-05-05

결정일2022-05-05

제품 코드GDW

자문 위원회SU

결정Substantially Equivalent

기기 요약

GIA Auto Suture Stapler with DST Series Technology is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221013. 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 GIA Auto Suture Stapler with DST Series Technology?

GIA Auto Suture Stapler with DST Series Technology is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Covidien. The 510(k) number is K221013.

When did GIA Auto Suture Stapler with DST Series Technology receive FDA 510(k) clearance?

GIA Auto Suture Stapler with DST Series Technology received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221013.

Who is the listed applicant for GIA Auto Suture Stapler with DST Series Technology?

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

What is the FDA product code for GIA Auto Suture Stapler with DST Series Technology?

The FDA product code for GIA Auto Suture Stapler with DST Series Technology is GDW.

Covidien를 신청인으로 등재한 기타 기록

K241486Sofsilk™ Coated Braided Silk Suture K240077Mon-a-Therm™ 일반 목적 온도探头 400TM (90050, 90044)K231934GIA™ Stapler with Tri-Staple™ Technology K231240MaxTack™ Motorized Fixation Device K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

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관련 기기 (코드: GDW)

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