FDA 510(k)

KARL STORZ ICG成像系统

K号: K202925 · 2020-12-17

决定日期2020-12-17

产品代码OWN

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决定实质等同

器械摘要

KARL STORZ ICG Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy_America, Inc.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K202925. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KARL STORZ ICG Imaging System?

KARL STORZ ICG Imaging System is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Karl Storz Endoscopy_America, Inc.. The 510(k) number is K202925.

When did KARL STORZ ICG Imaging System receive FDA 510(k) clearance?

KARL STORZ ICG Imaging System received FDA 510(k) clearance on 2020-12-17, under 510(k) number K202925.

Who is the listed applicant for KARL STORZ ICG Imaging System?

The FDA 510(k) record lists Karl Storz Endoscopy_America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ ICG Imaging System?

The FDA product code for KARL STORZ ICG Imaging System is OWN.

列明Karl Storz Endoscopy_America, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252624KARL STORZ 喉镜和附件 K240506KARL STORZ 托架 K223885HOPKINS 望远镜 K230359KOH 超微注射针 (26167NN)；吸引和冲洗针，L. 36cm (37360CP)；吸引和冲洗针，L. 36cm (37360SC)；吸引和冲洗针，L. 36cm (37560LH)；吸引和冲洗针，L. 30cm (37260LH)；KOH 超微注射针 (26167NA)；穿刺针，LUER-lock (26178R)；吸引和冲洗针，L. 43cm (37460LH)；吸引和冲洗针，L. 36cm (37360LH)；穿刺针，直径 1.6 mm，36 cm (26175R)；双向旋塞 (26167H)；注射针，LUER-K223520UNIDRIVE SIII 系统 K223923HOPKINS 望远镜

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官方来源

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