EndoDrill® 模型 X
K号: K212423 · 2023-03-29
广告
决定日期2023-03-29
产品代码FCG
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
EndoDrill® Model X is the device name listed in this FDA 510(k) record. The listed applicant is Bibbinstruments AB. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K212423. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EndoDrill® Model X?
EndoDrill® Model X is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Bibbinstruments AB. The 510(k) number is K212423.
When did EndoDrill® Model X receive FDA 510(k) clearance?
EndoDrill® Model X received FDA 510(k) clearance on 2023-03-29, under 510(k) number K212423.
Who is the listed applicant for EndoDrill® Model X?
The FDA 510(k) record lists Bibbinstruments AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EndoDrill® Model X?
The FDA product code for EndoDrill® Model X is FCG.
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：FCG）
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。
K252646单次使用细针穿刺活检(FNB)装置 (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA 和 FNB 类型Finemedix Co., Ltd.K241209EchoTip AcuCore™ EUS 细胞活检针 (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ 超声活检针 (ECHO-BX-3-22)Cook Ireland, Ltd.
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