FDA 510(k)

SureStrip 玻璃化吸管，SureLock 玻璃化吸管

K号: K203626 · 2021-06-04

决定日期2021-06-04

产品代码MQK

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

SureStrip Vitrification Straw, SureLock Vitrification Straw 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 2021-06-04 under 510(k) number K203626. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SureStrip Vitrification Straw, SureLock Vitrification Straw?

SureStrip Vitrification Straw, SureLock Vitrification Straw is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K203626.

When did SureStrip Vitrification Straw, SureLock Vitrification Straw receive FDA 510(k) clearance?

SureStrip Vitrification Straw, SureLock Vitrification Straw received FDA 510(k) clearance on 2021-06-04, under 510(k) number K203626.

Who is the listed applicant for SureStrip Vitrification Straw, SureLock Vitrification Straw?

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 SureStrip Vitrification Straw, SureLock Vitrification Straw?

The FDA product code for SureStrip Vitrification Straw, SureLock Vitrification Straw is MQK.

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 K200248Allwin胚胎移植导管（ETC），Allwin ETC型芯和软塞 K190659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 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 →

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。