FDA 510(k)

Karl Storz Radel灭菌托盘

K号: K203572 · 2021-05-07

决定日期2021-05-07

产品代码KCT

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决定实质等同

器械摘要

Karl Storz Radel Sterilization Trays 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 2021-05-07 under 510(k) number K203572. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Karl Storz Radel Sterilization Trays?

Karl Storz Radel Sterilization Trays is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K203572.

When did Karl Storz Radel Sterilization Trays receive FDA 510(k) clearance?

Karl Storz Radel Sterilization Trays received FDA 510(k) clearance on 2021-05-07, under 510(k) number K203572.

Who is the listed applicant for Karl Storz Radel Sterilization Trays?

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 Radel Sterilization Trays?

The FDA product code for Karl Storz Radel Sterilization Trays is KCT.

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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