FDA 510(k)

Endomat Select, IBS Shaver Software, License

K-번호: K201355 · 2020-07-22

결정일2020-07-22

제품 코드HIG

자문 위원회OB

결정Substantially Equivalent

기기 요약

Endomat Select, IBS Shaver Software, License is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K201355. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Endomat Select, IBS Shaver Software, License?

Endomat Select, IBS Shaver Software, License is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K201355.

When did Endomat Select, IBS Shaver Software, License receive FDA 510(k) clearance?

Endomat Select, IBS Shaver Software, License received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201355.

Who is the listed applicant for Endomat Select, IBS Shaver Software, License?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endomat Select, IBS Shaver Software, License?

The FDA product code for Endomat Select, IBS Shaver Software, License is HIG.

Karl Storz SE & CO. KG를 신청인으로 등재한 기타 기록

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)K254303KARL STORZ SUPRALOOP K261102UNIDRIVE Select System K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)K260884UNIDRIVE Select System K254103HOPKINS Telescopes for Arthroscopy

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