FDA 510(k)

Winch 骨盆成形术（15和20毫米）11号导丝球囊导管

K号: K152557 · 2016-02-23

决定日期2016-02-23

产品代码NDN

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： --- 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] --- 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

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is G21, S.R.L.. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K152557. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is G21, S.R.L.. The 510(k) number is K152557.

When did Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters receive FDA 510(k) clearance?

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance on 2016-02-23, under 510(k) number K152557.

Who is the listed applicant for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA 510(k) record lists G21, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA product code for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is NDN.

列明G21, S.R.L.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。

K252443SpaceFix Shoulder Spacer K223441SpaceFlex Acetabular Cup K202338SpaceFlex Shoulder K201960SpaceFlex Knee - 80mm Size K193061G3 40 显影骨水泥 K193059G1 40显影骨水泥

查看所有 11 个设备 →

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。