FDA 510(k)

Benesta 组织移除装置

K号: K233500 · 2023-11-30

决定日期2023-11-30

产品代码HIH

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决定实质等同

器械摘要

Benesta Tissue Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K233500. 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 Benesta Tissue Removal Device?

Benesta Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K233500.

When did Benesta Tissue Removal Device receive FDA 510(k) clearance?

Benesta Tissue Removal Device received FDA 510(k) clearance on 2023-11-30, under 510(k) number K233500.

Who is the listed applicant for Benesta Tissue Removal Device?

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

What is the FDA product code for Benesta Tissue Removal Device?

The FDA product code for Benesta Tissue Removal Device is HIH.

列明Caldera Medical, 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。

K211975Desara TV EZ 3.0 系统，Desara Blue TV EZ 3.0 系统，Desara TV EZ 2.7 系统，Desara Blue TV EZ 2.7 系统 K192811BenestaTM 组织移除装置 K192822Benesta 宫腔镜 K193603Benesta 医疗灭菌托盘 K191416Desara One 单切口吊带系统，1 套；Desara One 单切口吊带系统，3 套 K172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left

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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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