尿道前列腺支架，永久或半永久性
PMA编号：P250007 · 2025-12-11
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决定日期2025-12-11
PMA 编号P250007
产品代码MER
设备分类第3类
医疗专科U
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。
器械摘要
STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT is the device name listed in this FDA 510(k) record. The listed applicant is Zenflow, Inc.. It received FDA 510(k) clearance on 2025-12-11. The device is classified under product code MER. It was reviewed by the GU advisory panel.
常见问题
What is the STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT?
STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is Zenflow, Inc..
When did STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT receive FDA 510(k) clearance?
The clearance date for STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT can be found in the official FDA records.
谁是STENT，尿道，前列腺，永久或半永久产品的列名申请人？
The FDA 510(k) record lists Zenflow, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是STENT, URETHRAL, PROSTATIC, 永久或半永久产品的FDA产品代码？
FDA产品代码为STENT、URETHRAL、PROSTATIC、永久或半永久型的是MER。
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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