AirSurgN充气器（10030/AirSurgN）
K号: K242772 · 2025-04-11
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决定日期2025-04-11
产品代码HIF
咨询委员会OB
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决定实质等同
器械摘要
AirSurgN Insufflator (10030/AirSurgN) is the device name listed in this FDA 510(k) record. The listed applicant is SmartsurgN, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242772. 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 AirSurgN Insufflator (10030/AirSurgN)?
AirSurgN Insufflator (10030/AirSurgN) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is SmartsurgN, Inc.. The 510(k) number is K242772.
When did AirSurgN Insufflator (10030/AirSurgN) receive FDA 510(k) clearance?
AirSurgN Insufflator (10030/AirSurgN) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242772.
Who is the listed applicant for AirSurgN Insufflator (10030/AirSurgN)?
The FDA 510(k) record lists SmartsurgN, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirSurgN Insufflator (10030/AirSurgN)?
The FDA product code for AirSurgN Insufflator (10030/AirSurgN) 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SmartsurgN, 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.K252318充气器（OPTO-IFL1000）Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK243527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。
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