FDA 510(k)

UNIDRIVE SIII 系统

K号: K223520 · 2023-04-27

决定日期2023-04-27

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

UNIDRIVE SIII System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz-Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K223520. 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 UNIDRIVE SIII System?

UNIDRIVE SIII System is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Karl Storz-Endoscopy-America, Inc.. The 510(k) number is K223520.

When did UNIDRIVE SIII System receive FDA 510(k) clearance?

UNIDRIVE SIII System received FDA 510(k) clearance on 2023-04-27, under 510(k) number K223520.

Who is the listed applicant for UNIDRIVE SIII System?

The FDA 510(k) record lists Karl Storz-Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIDRIVE SIII System?

The FDA product code for UNIDRIVE SIII System is HIH.

列明Karl Storz-Endoscopy-America, 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。

K252624KARL STORZ 喉镜和附件 K240506KARL STORZ 托架 K223885HOPKINS 望远镜 K230359KOH 超微注射针 (26167NN)；吸引和冲洗针，L. 36cm (37360CP)；吸引和冲洗针，L. 36cm (37360SC)；吸引和冲洗针，L. 36cm (37560LH)；吸引和冲洗针，L. 30cm (37260LH)；KOH 超微注射针 (26167NA)；穿刺针，LUER-lock (26178R)；吸引和冲洗针，L. 43cm (37460LH)；吸引和冲洗针，L. 36cm (37360LH)；穿刺针，直径 1.6 mm，36 cm (26175R)；双向旋塞 (26167H)；注射针，LUER-K223923HOPKINS 望远镜 K221893KARL STORZ 双极切除镜带高频电缆

查看所有 46 个设备 →

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.

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。