FDA 510(k)

SB 刀 Jr 型，SB 刀短型，SB 刀标准型，SB 刀 Jr 型 - 长

K号: K152771 · 2016-06-17

决定日期2016-06-17

产品代码KNS

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决定实质等同

器械摘要

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K152771. 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 Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K152771.

When did SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long receive FDA 510(k) clearance?

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long received FDA 510(k) clearance on 2016-06-17, under 510(k) number K152771.

Who is the listed applicant for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

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

What is the FDA product code for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long?

The FDA product code for SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long is KNS.

列明Sumitomo Bakelite 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。

K182520柔性外套管 K190621SB 刀/短型，SB 刀/标准型，SB 刀/Jr 型，SB 刀/Jr 型 - 长 K173004SB 软帽 - 直型，SB 软帽 - 下切型

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

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