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FDA 510(k)

SmartBand EMR 套件 (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR 包装 (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR 六角套索 (SS-230-1 或套装中)

K号: K212860 · 2021-10-07

申请人STERIS Corporation
决定日期2021-10-07
产品代码FDI
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2021-10-07 under 510(k) number K212860. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)?

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) is a medical device that received FDA 510(k) clearance on 2021-10-07. The listed applicant is STERIS Corporation. The 510(k) number is K212860.

When did SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) receive FDA 510(k) clearance?

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) received FDA 510(k) clearance on 2021-10-07, under 510(k) number K212860.

Who is the listed applicant for SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)?

The FDA product code for SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) is FDI.

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列明STERIS Corporation为申报人的其他记录

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相关器械（代码：FDI）

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。

K251692高级组织切除设备Micro-Tech (Nanjing) Co., Ltd.K221713息肉圈套器Hangzhou AGS MedTech Co., Ltd.K220846CORE-SNAREIncore Co., Ltd.K220089一次性息肉圈套Jiangsu Vedkang Medical Science and Technology Co., Ltd.K220790一次性息肉切除术圈套，一次性息肉切除术混合圈套Yangzhou Fartley Medical Instrument Technology Co., Ltd.K213222一次性息肉切除术圈套Beijing Zksk Technology Co., Ltd.

官方来源

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