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FDA 510(k)

汤普森脑拉钩桌式（TM），汤普森脑拉钩颅骨夹式（SCM）

K号: K210615 · 2022-05-13

申请人Thompson Surgical Instruments, Inc.
决定日期2022-05-13
产品代码GZT
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决定实质等同

器械摘要

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is the device name listed in this FDA 510(k) record. The listed applicant is Thompson Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K210615. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Thompson Surgical Instruments, Inc.. The 510(k) number is K210615.

When did Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) receive FDA 510(k) clearance?

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) received FDA 510(k) clearance on 2022-05-13, under 510(k) number K210615.

Who is the listed applicant for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

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

What is the FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)?

The FDA product code for Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) is GZT.

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

相关器械（代码：GZT）

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。

K252995杜拉盾设备套件SurGenTec, LLCK202694Vycor Medical 视频脑部接入系统（“VBAS”）及配备对齐夹的 VBAS（统称为“VBAS 系列产品”）Vycor Medical, Inc.K202072MindsEye 可扩展端口Minnetronix Neuro, Inc.K180610Geister神经和脊柱手术拉钩Geister Medizin Technik GmbHK172433NICO BrainPathNico CorporationK161680MEDICON脊柱扩张系统Medicon EG

官方来源

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