FDA 510(k)

Luminelle DTx 宫腔镜系统，Luminelle 360 可旋转无菌一次性套管硬管

K号: K190827 · 2019-06-06

决定日期2019-06-06

产品代码HIH

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决定实质等同

器械摘要

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is the device name listed in this FDA 510(k) record. The listed applicant is Uvision360, Inc.. It received FDA 510(k) clearance on 2019-06-06 under 510(k) number K190827. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is a medical device that received FDA 510(k) clearance on 2019-06-06. The listed applicant is Uvision360, Inc.. The 510(k) number is K190827.

When did Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid receive FDA 510(k) clearance?

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid received FDA 510(k) clearance on 2019-06-06, under 510(k) number K190827.

Who is the listed applicant for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

The FDA 510(k) record lists Uvision360, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

The FDA product code for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is HIH.

列明Uvision360, 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。

K210512LUMINELLE DTx 系统 K192278Luminelle DTx 宫腔镜系统，Luminelle Dx 360 可旋转一次性套管（诊断）K181909Luminelle DTx 宫腔镜系统

相关器械（代码：HIH）

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。

K254252UNIDRIVE SIII 系统；霍普金斯望远镜 0º（26205AMA）操作套管（26205CD）闭孔器（26205OC）剃刀刀片（26205SA）剃刀刀片（26205SB）剃刀刀片（091133-01/-10）剃刀刀片（091134-01/-10）Karl Storz SE & CO. KG K261102UNIDRIVE选择系统Karl Storz SE & CO. KG K254294一次性使用数字宫腔镜（GYUT-A 12.6- 0，GYUT-A12.6- 12，GYUT-A 12.6- 22，GYUT-A 12.6- 30，GYUT-A 14.4- 0，GYUT-A 14.4- 12，GYUT-A 14.4- 22，GYUT-A 14.4- 30，GYUT-B 15- 0，GYUT-B 15- 12，GYUT-B 15-22，GYUT-B 15- 30）Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 切除装置（5FR1PK）；HERizon RD5 切除装置 - 5套装（5FR5PK）Axora Medical, Inc.K253020Strauss Surgical切除工具American Medical Endoscopy, Inc.K254050手动组织移除装置Suzhou AcuVu Medical Technology Co., Ltd.

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