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FDA 510(k)

SafePath Suturing System-Silk Suture，SafePath Suturing System Polyamide Suture（尼龙）SafePath Suturing System- Polypropylene Suture

K号: K222944 · 2024-10-18

申请人Safepath Medical, Inc.
决定日期2024-10-18
产品代码GAP
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture is the device name listed in this FDA 510(k) record. The listed applicant is Safepath Medical, Inc.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K222944. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Safepath Medical, Inc.. The 510(k) number is K222944.

When did SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture receive FDA 510(k) clearance?

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture received FDA 510(k) clearance on 2024-10-18, under 510(k) number K222944.

Who is the listed applicant for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

The FDA 510(k) record lists Safepath Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

The FDA product code for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture is GAP.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Safepath Medical, 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。

K180701SafePath Suturing System

相关器械（代码：GAP）

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。

K241486Sofsilk™涂层编织丝绸缝合线CovidienK232355不可吸收性外科丝线Shandong Haidike Medical Product Co., Ltd.K221767带或不带针的手术缝合线Huaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - 天然不可吸收丝手术缝合线，FILAMIDE - 不可吸收聚酰胺手术缝合线，MERICRON XL - 不可吸收聚酯手术缝合线，FILAPROP - 不可吸收聚丙烯手术缝合线M/s. Meril Endo Surgery Private Limited.K162396SILK外科缝合线Teleflexmedical, Inc.

官方来源

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