FDA 510(k)

유럽 연합 회전 스탬플러, 트리-스탬플 기술과 함께

K-번호: K221771 · 2022-11-30

결정일2022-11-30

제품 코드GDW

자문 위원회SU

결정Substantially Equivalent

기기 요약

EEA Circular Stapler with Tri-Staple Technology is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-11-30 under 510(k) number K221771. 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 EEA Circular Stapler with Tri-Staple Technology?

EEA Circular Stapler with Tri-Staple Technology is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Covidien. The 510(k) number is K221771.

When did EEA Circular Stapler with Tri-Staple Technology receive FDA 510(k) clearance?

EEA Circular Stapler with Tri-Staple Technology received FDA 510(k) clearance on 2022-11-30, under 510(k) number K221771.

Who is the listed applicant for EEA Circular Stapler with Tri-Staple 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 EEA Circular Stapler with Tri-Staple Technology?

The FDA product code for EEA Circular Stapler with Tri-Staple 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™ 스탬퍼스 with Tri-Staple™ 기술 K231240MaxTack™ Motorized Fixation Device K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)K232126EEA™원형 스탬퍼와 Tri-Staple™ 기술 및 OrVil™口腔 원형 스탬퍼 암톱

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관련 기기 (코드: GDW)

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