FDA 510(k)

ELRA 电极（7-2B11S，7-2B11L，7-2B22S，7-2B22L，7-4B18S，7-4B18L，7-4B33S，7-4B33L）

K号: K233113 · 2023-10-25

决定日期2023-10-25

产品代码KNS

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决定实质等同

器械摘要

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K233113. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)?

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K233113.

When did ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) receive FDA 510(k) clearance?

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) received FDA 510(k) clearance on 2023-10-25, under 510(k) number K233113.

Who is the listed applicant for ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)?

The FDA 510(k) record lists Starmed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)?

The FDA product code for ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) is KNS.

列明Starmed Co., Ltd.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。

K252833VIVA组合射频系统 K251566TS-RF Generator (STS10)K234140VIVA组合射频系统（VIVA组合射频系统）K222997VVR发生器系统 K203795Star RF 电极，VIVA RF 电极 K181758ELRA 电极

查看所有 11 个设备 →

相关器械（代码：KNS）

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。

K262460Rezum系统Boston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388征服水蒸气消融装置Francis Medical, Inc.K252889一次性3腔针刀V（KD-V441M，KD-V451M）Olympus Medical Systems Corporation K250945一次性预装括约肌刀V（远端导丝引导）（KD-VC600系列）；一次性括约肌刀V（远端导丝引导）（KD-VC400系列）；一次性三腔括约肌刀（KD-V系列）；一次性三腔括约肌刀（KD系列）Olympus Medical Systems Corp.K250351一次性电外科刀 (KD-612L, KD-612U)；一次性电外科刀 (KD-620UR)；一次性电外科刀 (KD-650L, KD-650U)Olympus Medical Systems Corporation

官方来源

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