FDA 510(k)

7D手术系统颅部活检和心室导管放置应用

K号: K192945 · 2019-11-27

决定日期2019-11-27

产品代码HAW

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决定实质等同

器械摘要

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical, Inc.. It received FDA 510(k) clearance on 2019-11-27 under 510(k) number K192945. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application?

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is a medical device that received FDA 510(k) clearance on 2019-11-27. The listed applicant is 7D Surgical, Inc.. The 510(k) number is K192945.

When did 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application receive FDA 510(k) clearance?

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application received FDA 510(k) clearance on 2019-11-27, under 510(k) number K192945.

Who is the listed applicant for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application?

The FDA 510(k) record lists 7D Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application?

The FDA product code for 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is HAW.

列明7D Surgical, 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。

K2104577D注册框架，7D Flex髂骨连接器，7D针引导块，7D 3.2 mm Steinmann针，7D髂嵴针夹与钥匙 K2105557D手术系统 - 钻孔引导 K2019667D手术FlashLock 1，7D手术Flex杆连接器 - 5.5 mm - 150 mm，7D手术Flex阵列 K1921407D手术系统 K1832767D手术系统 K1810417D手术系统颅部应用

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官方来源

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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。