充气器（OPTO-IFL1000）
K号: K252318 · 2026-04-16
广告
决定日期2026-04-16
产品代码HIF
咨询委员会OB
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Insufflator (OPTO-IFL1000) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Optomedic Technologies, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K252318. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Insufflator (OPTO-IFL1000)?
Insufflator (OPTO-IFL1000) is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Guangdong Optomedic Technologies, Inc.. The 510(k) number is K252318.
When did Insufflator (OPTO-IFL1000) receive FDA 510(k) clearance?
Insufflator (OPTO-IFL1000) received FDA 510(k) clearance on 2026-04-16, under 510(k) number K252318.
Who is the listed applicant for Insufflator (OPTO-IFL1000)?
The FDA 510(k) record lists Guangdong Optomedic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Insufflator (OPTO-IFL1000)?
The FDA product code for Insufflator (OPTO-IFL1000) is HIF.
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。
列明Guangdong Optomedic Technologies, 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。
相关器械（代码：HIF）
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。
K260209ENDOFLATOR+；智能烟雾排放器Karl Storz SE & CO. KGK252584充气器（wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C）Weyo Surgical Technology , Ltd.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN充气器（10030/AirSurgN）SmartsurgN, Inc.K243527高流量充气单元（UHI-4）Olympus Medical Systems CorporationK242536TauTona 腹腔充气辅助装置（TPAD）Tautona Group
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。
广告