免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Desara One 单切口吊带系统，1 套；Desara One 单切口吊带系统，3 套

K号: K191416 · 2020-02-07

申请人Caldera Medical, Inc.
决定日期2020-02-07
产品代码PAH
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack 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 2020-02-07 under 510(k) number K191416. The device is classified under product code PAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack?

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K191416.

When did Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack receive FDA 510(k) clearance?

Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack received FDA 510(k) clearance on 2020-02-07, under 510(k) number K191416.

Who is the listed applicant for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack?

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 Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack?

The FDA product code for Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack is PAH.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K233500Benesta 组织移除装置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

查看所有 8 个设备 →

相关器械（代码：PAH）

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。

K242473Altis单切口悬吊系统（519650）；Aris经闭孔悬吊系统（519551）；Supris经耻骨悬吊系统（519562）Coloplast Corp.K221874Altis单切口悬吊系统Coloplast A/S

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。

↑