FDA 510(k)

HTx一次性宫腔镜系统

K号: K231260 · 2024-03-05

申请人Suzhou AcuVu Medical Technology Co., Ltd.

决定日期2024-03-05

产品代码HIH

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决定实质等同

器械摘要

HTx Disposable Hysteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou AcuVu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K231260. 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 HTx Disposable Hysteroscope System?

HTx Disposable Hysteroscope System is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Suzhou AcuVu Medical Technology Co., Ltd.. The 510(k) number is K231260.

When did HTx Disposable Hysteroscope System receive FDA 510(k) clearance?

HTx Disposable Hysteroscope System received FDA 510(k) clearance on 2024-03-05, under 510(k) number K231260.

Who is the listed applicant for HTx Disposable Hysteroscope System?

The FDA 510(k) record lists Suzhou AcuVu Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HTx Disposable Hysteroscope System?

The FDA product code for HTx Disposable Hysteroscope System is HIH.

列明Suzhou AcuVu Medical Technology Co., Ltd.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。

K254050手动组织移除装置

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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