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FDA 510(k)

输尿管支架开放式尖端/闭合式尖端/术中尖端，经输尿管肾镜输尿管支架开放式尖端/闭合式尖端，儿童输尿管支架开放式尖端/闭合式尖端，单J型尿流改道输尿管支架开放式尖端/闭合式尖端，多环输尿管支架开放式尖端/闭合式尖端

K号: K190659 · 2019-12-02

申请人Allwin Medical Devices, Inc.
决定日期2019-12-02
产品代码FAD
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Unknown

器械摘要

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip is the device name listed in this FDA 510(k) record. The listed applicant is Allwin Medical Devices, Inc.. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K190659. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip?

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K190659.

When did Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip receive FDA 510(k) clearance?

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip received FDA 510(k) clearance on 2019-12-02, under 510(k) number K190659.

Who is the listed applicant for Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip?

The FDA 510(k) record lists Allwin Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip?

The FDA product code for Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip is FAD.

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。

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列明Allwin Medical Devices, 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。

K220781ARMADA 肾盂输尿管扩张器套装，ARMADA 诺丁汉一步扩张器，ARMADA Amplatz 肾脏扩张器套装，ARMADA 肾脏扩张器，Glider Amplatz 套管，ARMADA 肾脏扩张器带Amplatz套管，筋膜扩张器套装，导引套管，导引导管K220730allFlex 肾盂导管，Krait 肾盂导管K203626SureStrip 玻璃化吸管，SureLock 玻璃化吸管K200248Allwin胚胎移植导管（ETC），Allwin ETC型芯和软塞K190590Allwin卵母细胞采集针（ACE单腔卵母细胞采集针，OVUMPICK双腔卵母细胞采集针，ACE-FL单腔卵母细胞采集针带冲洗线，ACE-M手动单腔卵母细胞采集针）K190522Allwin宫腔内人工授精导管（INSEMINA和INSEMINA开放式尖端宫腔内人工授精导管，CURVED和CURVED开放式尖端宫腔内人工授精导管，TRACKABLE和TRACKABLE开放式尖端宫腔内人工授精导管，FLEXI和FLEXI开放式尖端宫腔内人工授精导管，STUMPY宫腔内人工授精导管）

查看所有 7 个设备 →

相关器械（代码：FAD）

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。

K251890一次性输尿管支架Zhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura®输尿管支架和支架套装Cathegenix (Xiamen) Co., Ltd.K243039输尿管支架（AF-D系列）Alton (Shanghai) Medical Instruments Co., Ltd.K243830一次性输尿管支架Shenzhen Trious Medical Technology Co., Ltd.K250824Percuflex输尿管支架；Percuflex Plus输尿管支架；Percuflex Plus SureDrive可弯曲输尿管支架套装；Contour输尿管支架；Contour SureDrive可弯曲输尿管支架套装；Contour VL可变长度输尿管支架；Contour VL SureDrive可弯曲输尿管支架套装；Polaris Ultra输尿管支架；Polaris Loop输尿管支架；Tria Firm输尿管支架；Tria Soft输尿管支架；Percuflex尿液分流支架套装Boston Scientific CorporationK232920RELIEF™ 肾盂支架套件；型号：RS-001 - 6 Fr x 24cm，RELIEF™ 肾盂支架套件；型号：RS-002 - 6 Fr x 26cmUreteral Stent Company

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