FDA 510(k)

Strauss Surgical切除工具

K号: K253020 · 2026-06-04

决定日期2026-06-04

产品代码HIH

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

Strauss Surgical Resection Instruments is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Endoscopy, Inc.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253020. 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 Strauss Surgical Resection Instruments?

Strauss Surgical Resection Instruments is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is American Medical Endoscopy, Inc.. The 510(k) number is K253020.

When did Strauss Surgical Resection Instruments receive FDA 510(k) clearance?

Strauss Surgical Resection Instruments received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253020.

Who is the listed applicant for Strauss Surgical Resection Instruments?

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

What is the FDA product code for Strauss Surgical Resection Instruments?

The FDA product code for Strauss Surgical Resection Instruments is HIH.

列明American Medical Endoscopy, 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。

K260271Strauss Surgical膀胱镜、宫腔镜和配件工具 K251652Strauss Surgical膀胱镜和宫腔镜（STS-2040-302ASA HD内窥镜，STS-2040-302AA HD内窥镜，STS-2040-302BA HD内窥镜，STS-2040-302BSA HD内窥镜，STS-2040-302ESA HD内窥镜，STS-2040-302CA HD内窥镜，STS-2029-302AA HD内窥镜，STS-2029-302BA HD内窥镜，STS-2040-298DSA-RWF内窥镜，STS-2040-298ASA-RWF内窥镜，STS-2040-300GSA-RWF内窥镜，STS-2040-303CA-RWF内窥镜，STS-2040-280ASA-OLY内窥镜，STS-2040-280ESA-OLY内窥镜，STS-2040-283BSA-OLY内窥镜）

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.K254050手动组织移除装置Suzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.

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。