Cannulated PsiFGuard
K号: K241895 · 2024-09-26
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申请人Spineguard
决定日期2024-09-26
产品代码SCY
咨询委员会OR
请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整：
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产品名称：[产品名称]
公司名称：[公司名称]
根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。
产品注册号：[注册号]
PMA编号：[PMA编号]
临床试验编号（NCT）：[NCT编号]
PubMed ID（PMID）：[PMID编号]
更多信息请访问以下链接：
[URL]
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请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同
器械摘要
Cannulated PsiFGuard is the device name listed in this FDA 510(k) record. The listed applicant is Spineguard. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241895. The device is classified under product code SCY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cannulated PsiFGuard?
Cannulated PsiFGuard is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Spineguard. The 510(k) number is K241895.
When did Cannulated PsiFGuard receive FDA 510(k) clearance?
Cannulated PsiFGuard received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241895.
Who is the listed applicant for Cannulated PsiFGuard?
The FDA 510(k) record lists Spineguard as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cannulated PsiFGuard?
The FDA product code for Cannulated PsiFGuard is SCY.
相关临床试验
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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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