FDA 510(k)

용기형 스타일러, 용기형 혈관종 스타일러, 용기형 선형 스타일러 및 리로드, 용기형 내시경 선형 컷터 스타일러 및 리로드

K-번호: K201639 · 2021-05-27

신청자Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

결정일2021-05-27

제품 코드GDW

자문 위원회SU

결정Substantially Equivalent

기기 요약

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-05-27 under 510(k) number K201639. 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 Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads?

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads is a medical device that received FDA 510(k) clearance on 2021-05-27. The listed applicant is Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. The 510(k) number is K201639.

When did Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads receive FDA 510(k) clearance?

Who is the listed applicant for Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads?

The FDA 510(k) record lists Beijing Biosis Healing Biolog Ical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads?

The FDA product code for Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads is GDW.

Beijing Biosis Healing Biolog Ical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K231513Oral Matrix K203622Medical Gloves K202844Medical Surgical Gowns K202029Medical Surgical Mask K201641용일식 라파로스코프 트로카 K201243용기 채취袋

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관련 기기 (코드: GDW)

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