带或不带针的手术缝合线
K号: K221767 · 2023-07-31
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决定日期2023-07-31
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
Surgical Sutures with or without Needle is the device name listed in this FDA 510(k) record. The listed applicant is Huaian Seamen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K221767. 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 Surgical Sutures with or without Needle?
Surgical Sutures with or without Needle is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Huaian Seamen Medical Technology Co., Ltd.. The 510(k) number is K221767.
When did Surgical Sutures with or without Needle receive FDA 510(k) clearance?
Surgical Sutures with or without Needle received FDA 510(k) clearance on 2023-07-31, under 510(k) number K221767.
Who is the listed applicant for Surgical Sutures with or without Needle?
The FDA 510(k) record lists Huaian Seamen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Surgical Sutures with or without Needle?
The FDA product code for Surgical Sutures with or without Needle 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。
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CovidienK222944SafePath Suturing System-Silk Suture，SafePath Suturing System Polyamide Suture（尼龙）SafePath Suturing System- Polypropylene SutureSafepath Medical, Inc.K232355不可吸收性外科丝线Shandong Haidike Medical Product 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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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