FDA 510(k)

allFlex 肾盂导管，Krait 肾盂导管

K号: K220730 · 2022-10-13

决定日期2022-10-13

产品代码KOD

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决定实质等同

器械摘要

allFlex Ureteral Catheters, Krait Ureteral Catheters 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 2022-10-13 under 510(k) number K220730. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the allFlex Ureteral Catheters, Krait Ureteral Catheters?

allFlex Ureteral Catheters, Krait Ureteral Catheters is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Allwin Medical Devices, Inc.. The 510(k) number is K220730.

When did allFlex Ureteral Catheters, Krait Ureteral Catheters receive FDA 510(k) clearance?

allFlex Ureteral Catheters, Krait Ureteral Catheters received FDA 510(k) clearance on 2022-10-13, under 510(k) number K220730.

Who is the listed applicant for allFlex Ureteral Catheters, Krait Ureteral Catheters?

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 allFlex Ureteral Catheters, Krait Ureteral Catheters?

The FDA product code for allFlex Ureteral Catheters, Krait Ureteral Catheters is KOD.

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 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 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）

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