KARL STORZ UDEL灭菌托盘
K号: K201945 · 2021-02-25
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决定日期2021-02-25
产品代码KCT
咨询委员会医疗设备监管文本翻译如下：
HO
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器械摘要
KARL STORZ UDEL 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 2021-02-25 under 510(k) number K201945. 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 UDEL Sterilization Trays?
KARL STORZ UDEL Sterilization Trays is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K201945.
When did KARL STORZ UDEL Sterilization Trays receive FDA 510(k) clearance?
KARL STORZ UDEL Sterilization Trays received FDA 510(k) clearance on 2021-02-25, under 510(k) number K201945.
Who is the listed applicant for KARL STORZ UDEL 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 UDEL Sterilization Trays?
The FDA product code for KARL STORZ UDEL Sterilization Trays is KCT.
相关临床试验
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。
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
相关器械（代码：KCT）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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