FDA 510(k)

SB 刀 Jr2 (MD-47702 和 MD-47702L)

K号: K241855 · 2025-03-26

决定日期2025-03-26

产品代码KNS

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决定实质等同

器械摘要

SB Knife Jr2 (MD-47702 and MD-47702L) is the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K241855. 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 SB Knife Jr2 (MD-47702 and MD-47702L)?

SB Knife Jr2 (MD-47702 and MD-47702L) is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K241855.

When did SB Knife Jr2 (MD-47702 and MD-47702L) receive FDA 510(k) clearance?

SB Knife Jr2 (MD-47702 and MD-47702L) received FDA 510(k) clearance on 2025-03-26, under 510(k) number K241855.

Who is the listed applicant for SB Knife Jr2 (MD-47702 and MD-47702L)?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SB Knife Jr2 (MD-47702 and MD-47702L)?

The FDA product code for SB Knife Jr2 (MD-47702 and MD-47702L) is KNS.

列明Sb-Kawasumi Laboratories, 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。

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET 带高压软管 K230408K-SHIELD Zen (型号：PBMH/ PBMA/ PBM)K223810Kawasumi多样本适配器带预装夹具（MBCH）K220799K-SHIELD Zen

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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